1) Model: XN-10; Catalog Number: AP795756; Serial Numbers: 111001-15483 except 15287, 15298, 15308, 15408, 15442, 15454, 15470 and 15484;   2) Model: XN-20; Catalog Number: AE797961; Serial Numbers: 11001-12118 except 11960, 12039, 12078, 12114, and 12117.

Hematology and Pathology Devices

2

No

Worldwide Distribution - US to AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY + District of Columbia + Guam; Internationally to Australia, Bahrain, Bangladesh, Cambodia, Canada, China, Germany, Hong Kong, India, Indonesia, Malaysia, Maldives, Mongolia, Mynamar, Nepal, New Zealand, Pakistan, Philippines, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, and Vietnam. THE CORRECTION IS LIMITED TO XN-10/XN-20 UNITS DISTRIBUTED BY SYSMEX AMERICA, INC., INSTALLED AT END-USER SITES IN US, PUERTO RICO, AND CANADA.

The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

Product Code: NCL-L-CD15; Lot Numbers and Expiration Dates: Lot 6022274, Expiry 2015-04; Lot 6024628, Expiry 2015-08; Lot 6030581, Expiry 2016-07

Hematology and Pathology Devices

1

No

Worldwide Distribution - US Nationwide in the states of CA, CT, FL, IA, ID, IL, MT, NC, NY, TX, WA and in the countries of: Argentina, Australia, Bosnia and Herzegovina, Brazil, Canada, Chile, Denmark, El Salvador, France, Germany, Hungary, India, Italy, Japan, Netherlands, Nigeria, Portugal, Romania, Russia, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, United Arab Emirates, United Kingdom.

Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. || Product Usage: NCL-L-CD15 is intended for the qualitative identification by light microscopy of CD15 molecules in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patients clinical history and other diagnostic tests by a qualified pathologist.

Lot numbers 4155632 with expiry date of 2015-06-30.  Lot 42889687 was not shipped to customers.

Hematology and Pathology Devices

1

No

US Nationwide Distribution in the states of CA, NY, and MI

Anti-Lambda APC-H7, Catalog Number 656157. || Product Usage: || Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.

Lot number 4220622, Expiry 2016-04-30.

Hematology and Pathology Devices

2

No

Worldwide distribution. US Nationwide including Puerto Rico, China, Brazil, Japan, Guatemala, India, New Zealand, Australia, Canada, Thailand, Chile and Malaysia.

CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. || Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions.

Lot numbers: HMO 9200  HMO 9217  HMO 9226  HMO 9232  HMO 9276  HMO 9285  HMO 9292 Exp. Date 1/2017

Hematology and Pathology Devices

2

No

Worldwide Distribution -- US, Canada, Czech Republic, Denmark, Great Britain, and Sweden.

Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. || Level II Control is a biological control for use with the Thrombelastograph (TEG) Hemostasis System.

992640 Rev. 02, 992085 Rev.no H, 992625 Rev.no F, 992326 Rev.no C  Affected dates: 12/2013-08/2014  Each device is labeled with a unique serial number.  Catalog/Model Number: - AS480 - S3800 - S3400 - AS100

Hematology and Pathology Devices

1

No

Worldwide Distribution: US (nationwide) and countries of: AT, AU, BE, CA, CH, DE, DK, ES, FR, GB, IE, IT, JP, NL, NO, PL, and SE.

Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro diagnostic use.

Lot: 313833 Expiration date: 11/2016

Hematology and Pathology Devices

1

No

US, Canada and Europe

Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon; Size: 1 Gallon/3.8L; LOT 313833; 11/2016; Bottle: Richard-Allan Scientific CYTO-STAIN G; REF 7501G; 1 Gallon/3.8L; Thermo Scientific.

Serial Nos. E34297300656, E34297300657, E34297300659, E34297300660, E34297300661, E34297300666, E34297300667, E34297300668, E34297300669, E34297300670, E34297300671, E34297300673, E34297300675, E34297300676, E34297300677, E34297300678  E34297502563, E34297502564, E34297502565, E34297502566, E34297502567, E34297502568, E34297502569, E34297502570, E34297502571, E34297502572, E34297502573, E34297502574, E34297502575, E34297502576, E34297502577, E34297502578, E34297502579, E34297502580, E34297502581, E34297502583, E34297502584, E34297502585, E34297502586, E34297502587, E34297502588, E34297502589, E34297502590, E34297502591, E34297502592, E34297502593, E34297502594, E34297502595, E34297502596, E34297502597, E34297502599, E34297502600, E34297502601, E34297502602, E34297502603, E34297502604, E34297502605, E34297502606, E34297502607, E34297502608, E34297502612, E34297502613, E34297502619, E34297502620, E34297502621, E34297502629, E34297600499, E34297600501, E34297600502, E34297600503, E34297600507, E34297600508.

Hematology and Pathology Devices

2

No

Worldwide Distribution -US including TX, NJ, and OK and Internationally to Hong Kong, Japan, Singopore, and Belguim

BD FACSCalibur; || Catalog Numbers 342973, 342975, 34976 || In vitro Diagnostics Use.

Lot 5008762, Exp 11/30/16.

Hematology and Pathology Devices

1

No

US Distribution in states of: MO, GA, AZ, NE, TX, VA

CD123 (9F5) PE || Catalog number 649453 || Analyte Specific Reagent

Catalog number PM008 AA; Lot numbers: 110912, Exp 2015/11; 041913, Expiry 2016/04; 120313, Expiry 2016/12; 110314, Expiry 2017/11.

Hematology and Pathology Devices

1

No

Worldwide Distribution - US nationwide in the states of TX, KS, OK, NJ, LA, GA, NC, SC, VA, and the countries of Spain, Austria, Ecuador, Dominican Republic, Vietnam, Kuwait, Hungary and Israel.

CD99 || Catalog number PM008 AA; || For In Vitro Diagnostic Use. || Product Usage: || Provides adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology methods.

Catalog number: PM266AA, lot 030615, Expiration: 2018/03.

Hematology and Pathology Devices

1

No

Worldwide Distribution - US Nationwide in the states of: MI, SC, NC, AZ, CA, MO, WI and Hungary, Spain and Austria.

D2-40 (Lymphatic Marker); For In Vitro Diagnostic; || Catalog number: PM266AA || Product Usage: || In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry (ICH) in formalin fixed paraffin embedded human tissues.

10454742 10454729 10461894 10470625

Hematology and Pathology Devices

2

No

Worldwide Distribution -- Austria, Bulgaria, Belgium, Switzerland, Cyprus, Czech Republic, Germany, Denmark, Italy, Latvia, Netherlands, Poland, Portugal, Romania, Sweden, Slovenia, Slovakia, Turkey, Croatia, Bahrain, Belarus, Bosnia-Herzegovina, Guadeloupe, Kuwait, Lebanon, Libya, Macedonia, Montenegro, Qatar, Russia, San Marino, Saudi Arabia, Serbia, South Africa, United Arab Emirates, Argentina, Brazil, Chile, El Salvador, Peru, China, Mexico, Canada and United States.

Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP System. || In vitro diagnostic reagent for the determination of the activity of coagulation factor IX in human plasma by coagulometric methods.

Catalog Number B4218-1, Material Number 10445709, lot numbers 557128, 557129, 557130, 557131, 557132, 557133, 557134, 557135, 557140, 557141 , expiration dates:10/31/2015, 11/21/2015, 2/16/2016

Hematology and Pathology Devices

2

No

Worldwide Distribution. US naionwide including Puerto Rico, Barbados and Mexico.

Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the determination of the activated partial thromboplastin time (APTT) and other coagulation procedures requiring an activated partial thromboplastin reagent.

Catalog # 021446, Lot # H7-111W, Exp. Date 10-2015

Hematology and Pathology Devices

2

No

Us Nationwide Distribution in the state ID including PR.

G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. || Product Usage: || G7 Variant Elution Buffer HiS No 1. (M) is one of the buffers used on Tosoh Automated Glycohemoglobin Analyzer HLC 723G7.

Material No. Serial No. 343202 E0565, 343202 E3190, 338960 V96100212, 338962 V96300187, 338962 V96300189, 342975 E97500564, 338962 V96300231, 342975 E97500700, 33300472 H47200110, 338962 V96300567, 338960 V96100817, 338960 V96100911, 338960 V96100913, 338962 V96300761, 338960 V96101255, 648063 H06300007, 647793 H79300005, 343276 E4731, 337175 V07300249, 647785 H64778500001, 647793 H64779300011, 338960 V33896101603, 338962 V33896301405, 340128 W91100061, 340128 W91100104, 343202 E0035, 343202 E0108, 343202 E0692, 343202 E0849, 343202 E3313, 343202 E3355, 343023 E0722, 343023 E1312, 343023 E3108, 654899 V96101131, 340469 P46900047, 644655 00-00059-00, 340551 H47100064, 644655 00-00068-00, 340469 P46900070, 341360 P22300058, 342975 E97500699, 340469 P46900093, 644655 00-00065-00, 643695 P69500019, 340551 H47100133, 643178 P17800016, 643695 P69500029, 643695 P69500031, 338960 V96100758, 340551 H47100171, 340551 H47100180, 340551 H47100193, 340551 H47100197, 643182 P18200019, 341360 P0324, 644655 00-00027-00, 643695 P69500082, 643695 P69500093, 338960 V96101018, 334079 P1003, 644655 Z65500010, 340551 H55100016, 650036 P03600001, 646500 X5000040, 649225 H5B400031, 650109 P10900001, 338960 V33896101581, 647177 H64717700006, 343020 E1774, 343202 E2583, 343268 SE0060, 644655 00-00023-00, 654899 V96100174, 340469 P46900074, 343276 E0511, 340469 P46900092, 340469 P46900091, 340551 H47100089, 338960 V96100546, 338960 V96100172, 342975 E97501071, 340551 H47100177, 643695 P69500103, 643695 P69500104, 340551 H47100229, 340551 H47100234, 647800 H80000006, 338962 V96301224, 643695 P69500081, 343020 E0337, 342975 E97500077, 342975 E97500509, 342975 E97500510, 342975 E97501195, 33717508 V0013, 337175 V07300219, 338962 V96301195, 333999 P99900028, 342975 E97500606, 338960 V96100320, 342973 E97300244, 342975 E97501014, 450500 D08932049, 342976 E97600314, 641548 V96100195, 340551 H47100030, 340551 H47100066, 340551 H47100111, 340551 H47100113, 338960 V96100602, 338960 V96100613, 340551 H47100143, 342975 E97501009, 340128 W91100272, 340551 H47100198, 338960 V96100852, 338960 V96100855, 340551 H47100205, 647177 H17700010, 647785 H78500003, 649225 H5B400009, 340551 H55100027, 649225 H5B400011, 649225 H5B400027, 340128 W91100317, 647800 H80000015, 338962 V33896301359, 343020 E0249, 343202 E5801, 338960 V33896100001, 343073 D0311, 343073 D0644, 342975 E97500467, 342975 E97500618, 342975 E97500994, 342975 E97501260, 342975 E97501126, 338962 V33896301379, 343020 E1262, 343202 E0637, 34320208 E0956, 343202 E0983, 343202 E1124, 343202 E1310, 343023 E0131, 343023 E0678, 340128 W91100290, 33947308 V87500121, 343020 E0329, 343020 E0786, 343202 E0051, 343202 E0178, 343202 E0326, 338960 V96100250, 338962 V96300191, 338960 V96100443, 643695 P69500020, 339473 V87500062, 34297508 E97501010, 339473 V87500066, 338962 V96300519, 338962 V96300649, 338962 V96300719, 338960 V96101104, 338960 V96101111, 643554 V96101177, 338960 V96101406, 338962 V96301189, 338962 V96301190, 338960 V96101491, 338962 V96301268, 343260 E97300268, 342975 E97500506, 340551 H47100047, 343276 E3420, 33407808 P07800142, 33300472 H47200088, 338960 V96100396, 338960 V96100423, 338960 V96100680, 340551 H47100151, 643695 P69500042, 643181 P18100021, 338960 V96100750, 338962 V96300716, 338960 V96101044, 643554 V96300790, 647794 H79400009, 343276 E4421, 645054 P0072, 643178 P17800075, 342975 E97501624, 649225 H5B400034, 334225 PILOT017, 340128 W91100128, 343020 E0023, 343020 E3600, 343202 E0575, 343202 E1167, 343202 E1251, 343202 E2635, 343202 E3052, 338960 V96100616, 33896008 V96100617, 343276 E0049, 644655 00-00071-00, 644655 00-00075-00, 644655 00-00086-00, 644655 00-00082-00, 644655 00-00026-00, 644655 Z65500006, 646500 X5000028, 646500 X5000034, 646500 X5000035, 646500 X5000039, 646500 X5000043, 646500 X5000044, 646500 X5000045, 646500 X64650000047, 343202 E0107, 343202 E0799, 343202 E0838, 343202 E1126, 343202 E1223, 343202 E1264, 343202 E1293, 343202 E1377, 34302308 E1120, 343023 E1133, 338962 V96300178, 342976 E97600122, 342975 E97500614, 338962 V96300294, 342973 E97300193, 343277 E0532, 342975 E97500821, 342975 E97500928, 342975 E97501147, 342975 E97501148, 338962 V96300693, 343276 E97501574, 342975 E97501584, 342975 E97501589, 338962 V96301263, 338962 V96301264, 338962 V33896301355, 338962 V33896301377, 343020 E1109, 343020 E3025, 343022 E0018, 34320208 E0059, 343020 E0330, 34320208 E0907, 342975 E97500513, 34297508 E97500592, 342975 E97500701, 342975 E97500710, 342975 E97501023, 342975 E97501037, 342975 E97501086, 343023 E0140, 338960 V96100216, 338962 V96301027, 338962 V96300203, 34012809 PILOT012, 340469 P46900052, 340128 W91100224, 343276 E1316, 338960 V96100530, 338960 V96100646, 643695 P69500048, 340551 H47100187, 340551 H47100196, 338960 V96101216, 338962 V96301246, 648282 P28200193, 338960 V33896101594, 343020 E0455, 343202 E0218, 343202 E0364, 344860 W91100170, 340469 P46900068, 338960 V96100343, 340551 H47100081, 338960 V96100496, 340469 P46900100, 338960 V96100642, 338960 V96100669, 338960 V96100634, 344860 W91100263, 338960 V96100741, 338960 V96100667, 340551 H47100162, 338960 V96100688, 643695 P69500060, 339473 V87500075, 338962 V96301007, 338962 V96301008, 645054 P0038, 338962 V96300795, 643695 P69500151, 650110 P11000003, 650110 P11000009, 338960 V96101508, 645054 P28200099, 343202 E1069, 338962 V96301162, 34307308 D0513, 340551 H47100080, 340469 P46900095, 340551 H47100095, 340551 H47100122, 340551 H47100121, 342975 E97501007, 340551 H47100170, 643178 P17800024, 340551 H47100183, 33300482 H48200062, 643695 P69500062, 647793 H79300001, 340551 H55100002, 648068 H06800002, 342976 E97600294, 648064 H06400001, 643181 P18100049, 340551 H55100009, 643695 P69500129, 650110 P11000006, 342973 E97300459, 340551 H55100035, 648282 P64828200001, 343020 E0567, 343022 E0685, 343202 E0794, 343023 E1237, 343023 E1252, 343202 E1330, 343020 E0210, 343022 E0919, 343202 E0277, 343202 E0366, 343202 E0406, 343202 E0684, 34297508 E5871, 343276 E97500706, 343023 E0273, 343023 E0305, 64465508 Z65500007, 646500 X5000001, 648282 P28200018, 648282 P28200017, 645054 P69500140, 646500 X5000002, 646500 X5000030, 646500 X5000033, 644655 Z65500002, 644655 Z65500003, 644655 Z65500009, 338960 V96100185, 340551 H47100038, 338962 V96300264, 342975 E97501003, 338960 V96100745, 338962 V96300560, 33300476 H47600118, 33896008 V96100815, 340551 H47100237, 33300482 H48200071, 338962 V96300809, 338962 V96300810, 338960 V96101164, 643554 V96101250, 338960 V96101490, 338960 V33896101609, 343202 E0784, 343202 E1456, 340551 H47100065, 645054 P46900096, 340469 P46900102, 338962 V96300420, 643695 P69500016, 643695 P69500018, 643177 P17700014, 643178 P17800021, 643695 P69500043, 643695 P69500085, 643177 P17700042, 340551 H55100006, 643695 P69500119, 647177 H17700016, 648282 P28200049, 647800 H80000008, 650034 P03400001, 650110 P11000010, 647177 H17700009, 342973 E97300491, 647785 H64778500002, 343202 E0810, 343023 E0054, 343023 E0949, 339101 H0080, 338960 V96100246, 340469 P46900066, 338960 V96100329, 340469 P46900069, 338962 V96300297, 341360 P07900069, 643177 P17700004, 339473 V87500060, 643181 P18100043, 338960 V96100983, 643178 P17800054, 643695 P69500114, 343276 E3045, 643695 P69500148, 643695 P69500150, 650052 P05200001, 648282 P28200142, 338962 V96301247, 648282 P28200188, 643695 P69500158, 334079 P07900013, 650110 P65011000032, 343020 E1326, 343202 E0257, 343202 E1318, 33300478 H47800076, 342975 E97500776, 338960 V96100545, 342975 E97500938, 33300472 H47200112, 342973 E97300398, 342975 E97501405, 342976 E97600317.338960 V96101488, 338962 V33896301357, 343202 E0251, 343202 E1311, 34320208 E3175, 343202 E3976, 343023 E0203, 338960 V96100598, 338960 V96100705, 338962 V96300898, 338962 V96300030, 338960 V96101392, 343202 E1027, 34320208 E5800, 343023 E1315, 343023 E5609, 338962 V96300173, 338962 V96300210, 338962 V96300217, 338960 V96100288, 343276 E2509, 342973 E97300212, 33300476 H47600102, 338960 V96101504, 343020 E0072, 343020 E0840, 343202 E1042, 343023 E0804, 337175 V07300435, 340551 H47100028, 341360 P07900060, 333999 P99900030, 335223 P22300096, 340469 P46900076, 643695 P69500004, 643695 P69500010, 340551 H47100238, 643695 P69500099, 643695 P69500106, 643695 P69500113, 643695 P69500125, 339101 H47100155, 643695 P69500135, 648282 P28200007, 648282 P28200022, 643695 P69500152, 648282 P28200075, 647177 H17700025, 647177 H17700032, 647794 H6477940000024, 340469 P46900042, 340469 P46900045, 338960 V96100359, 340128 W91100225, 340469 P46900090, 338962 V96300367, 643695 P69500002, 338960 V96100624, 643695 P69500047, 643554 V96100899, 338962 V96300728, 647800 H80000001, 338962 V96300820, 338962 V96301057, 339101 H47100022, 643181 P18100060, 338962 V96301194, 647785 H78500004, 338960 V96101497, 338960 V96101524, 643554 V33896101564, 343202 E0233, 34320208 E0371, 343202 E0782, 343023 E0105, 343023 E0199, 338962 V96300221, 338962 V96301109, 340551 H47100036, 338960 V96100291, 33300476 H47600092, 342975 E97500658, 33300482 H48200053, 340128 W91100223, 340551 H47100084, 340551 H47100102, 338960 V96100536, 340128 W91100243, 338960 V96100590, 642324 W91100113, 33300472 H47200108, 340551 H47100201, 340551 H47100210, 340551 H47100206, 340551 H47100208, 338960 V96100882, 343276 E5572, 340128 W91100277, 647177 H17700003, 340551 H55100005, 647177 H17700007, 647177 H17700020, 649225 H5B400003, 338960 V96101325, 338962 V96301213, 647177 H17700033, 649225 H5B400043, 338960 V96101537, 643554 V33896100002, 643554 V33896101563, 34008860 D0050, 343073 D0893, 342975 E97500546, 342975 E97500593, 342975 E97500601, 342975 E97501089, 343202 E0168, 343202 E0480, 343202 E0570, 343202 E20200172, 343202 E2080, 343202 E4394, 343202 E5978, 343023 E0080, 343023 E0577, 338960 V96100243, 343276 E2482, 338962 V96300320, 34326008 E0454, 338960 V96100449, 338960 V96100555, 338960 V96100666, 338962 V96300824, 343022 E0700, 343202 E2711, 34307308 D0940, 342975 E97500557, 343202 E0841, 340469 P46900056, 338960 V96100406, 334078 P07800167, 643181 P18100009, 338960 V96100682, 647794 H79400004, 643695 P69500079, 643695 P69500133, 339101 H10100013, 647177 H17700021, 338962 V96301116, 338962 V96301187, 648282 P28200112, 650034 P03400004, 338962 V96301327, 647794 H79400019, 647794 H79400020, 650110 P65011000026, 650110 P65011000027, 338962 V96300397, 338962 V96300460, 343268 C0167, 342975 E97500665, 342975 E97500823, 343260 E1714, 342976 E97600244, 338960 V96101222, 343276 E3984, 343276 E2825, 343020 E0929, 343202 E0068, 343202 E0069, 34320208 E0097, 343202 E0778, 343202 E0798, 343202 E1169, 343202 E1368, 343202 E1960, 343202 E3198, 34008860 D0254, 645054 P46900039, 338960 V96100286, 338960 V96100344, 340469 P46900081, 33300476 H47600097, 338960 V96100413, 338962 V96300307, 338962 V96300370, 338960 V96100586, 338960 V96100594, 338962 V96300010, 33300472 H47200101, 339101 H47100149, 340551 H47100189, 643695 P69500068, 338960 V96100997, 342975 E97501293, 647785 H78500001, 343276 E5337, 647780 H78000001, 643695 P69500124, 340551 H55100018, 647793 H79300004, 338960 V96101403, 342973 E97300463, 343020 E0240, 343020 E1327, 342975 E97501559, 335860 V07300514, 33896208 V96301102, 335223 P22300094, 340469 P46900061, 340469 P46900063, 340469 P46900067, 334078 P07800155, 340469 P46900073, 340469 P46900080, 334078 P07800161, 334078 P07800163, 335223 P22300095, 643695 P69500012, 643695 P69500083, 643695 P69500116, 648282 P28200090, 648282 P28200105, 648282 P28200138, 338960 V96100244, 340551 H47100059, 338960 V96100402, 338960 V96100436, 338960 V96100467, 338960 V96100397, 338962 V96300364, 338960 V96100609, 340551 H47100123, 342973 E97300270, 338962 V96300435, 343276 E3983, 338960 V96100712, 338962 V96300524, 338960 V96100746, 340551 H47100174, 33300472 H47200104, 338960 V96100686, 338960 V96100792, 338960 V96100794, 338960 V96100954, 647800 H80000002, 338960 V96101135, 338962 V96300107, 342975 E97501497, 338962 V96301165, 649225 H5B300003, 648088 H08800004, 338962 V96301245, 338960 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649225 H5B300014, 338962 V96301126, 343020 E0223, 343202 E0195, 34320208 E3469, 343202 E4143, 337858 D858000559, 337858 D858002030, 340128 W91100203, 33300478 H47800077, 643695 P69500017, 33300476 H47600109, 33300478 H47800087, 643695 P69500086, 643695 P69500115, 650110 P65011000030, 343268 C0051, 34326808 C0319, 34326808 C0322, 343268 C0361, 341360 P46900006, 643695 P69500023, 643695 P69500040, 338962 V96300653, 643695 P69500080, 649225 H649225B7013, 343023 E0181, 343023 E1117, 343023 E1337, 343268 C0317, 341894 H0087, 339101 H0084, 643188 P18800014, 338962 V96300008, 338962 V96300012, 337858 D858000396, 337858 D858000469, 333004 H1064, 33300482 H48200031, 339101 H0006, 340469 P46900043, 338962 V96100285, 340551 H47100063, 338960 V96100337, 338960 V96100407, 340551 H47100078, 641548 V07300625, 643695 P69500025, 643695 P69500089, 338962 V96300874, 343261 E3437, 649225 H5B400064, 338962 V33896301404, 343022 E0754, 343023 E0738, 343186 D0133, 34008860D D0280, 340551 H47100044, 339101 H0155, 334078 P07800162, 340551 H47100082, 643695 P69500015, 643695 P69500033, 643695 P69500056, 643178 P17800027, 643695 P69500091, 646500 Z65500011, 643695 P69500095, 647794 H79400001, 643695 P69500118, 340551 H55100007, 646500 X5000029, 340551 H55100021, 340551 H55100030, 647780 H78000004, 650110 P11000023, 340551 H3405510000040, 343022 E0177, 343202 E0788, 340551 H47100033, 340551 H47100046, 338960 V96100239, 338960 V96100242, 340551 H47100034, 340551 H47100057, 338962 V96300135, 338960 V96100652, 338962 V96300528, 342976 E97600197, 338960 V96100867, 340551 H47100231, 648064 H06400003, 338960 V96101172, 338960 V96101175, 338962 V96300992, 338962 V96301079, 649225 H5B400041, 649225 H5B400030, 343023 E3242, 342975 E97501454, 343276 E97501456, 343023 E0296, 338960 V96101327, 338960 V96101341, 33300476 H47600096, 340469 P46900083, 334079 P07900209, 340551 H47100085, 643182 P18200015, 33300476 H47600115, 643185 P18500001, 643178 P17800032, 643178 P17800037, 643182 P18200026, 643695 P69500110, 643181 P18100046, 647177 H17700005, 647177 H17700011, 649225 H5B200003, 648282 P28200122, 648282 P64828200008, 341360 P0375, 339101 H0144, 340551 H47100053, 338962 V96300228, 340469 P46900058, 343277 E0906, 340469 P46900087, 340551 H47100093, 339101 H0138, 340551 H47100110, 643695 P69500014, 340551 H47100145, 643187 P18700002, 340551 H47100175, 643695 P69500041, 643695 P69500052, 342975 E97501090, 643695 P69500063, 643695 P69500064, 338962 V96300695, 647785 H78500002, 643695 P69500122, 643177 P17700053, 643178 P17800066, 643695 P69500144, 648282 P28200027, 643695 P69500147, 648282 P28200034, 338962 V96300726, 649225 H5B500024, 343276 E5284, 647794 H64779400025, 647177 H64717700002, 643180 P18000009, 343202 E1280, 343202 E5451, 343268 C0368, 33300471 H47100020, 33300472 H47200102, 342975 E97500454, 338960 V96100197, 34297508 E97500578, 338960 V96100279, 338960 V96100350, 338962 V96300286, 338960 V96100503, 338960 V96100559, 338962 V96300422, 338960 V96100651, 340551 H47100140, 342974 E97400040, 338962 V96300946, 338960 V96101109, 338962 V96301055, 340551 H55100029, 339473 V87500113, 342976 E97600366, 343202 E0733, 343202 E0985, 343202 E3995, 343023 E0443, 338960 V33896101557, 338960 V33896101558, 338960 V96100342, 338960 V96100444, 338960 V96100621, 338962 V96300417, 338962 V96300224, 338962 V96300273, 338960 V96100535, 338962 V96300512, 338962 V96300518, 338962 V96300556, 643695 P69500059, 338962 V96300577, 342975 E97501267, 338962 V96300847, 338962 V96300864, 643695 P69500132, 648282 P28200071, 648282 P28200110, 650049 P65004900001, 343202 E0267, 343202 E0687, 343202 E0796, 343202 E3201, 343276 E5389, 338960 V96100263, 339101 H0146, 338962 V96300282, 338962 V96300278, 338960 V96100422, 339101 H0016, 340551 H47100125, 338962 V96300447, 338960 V96100763, 338962 V96300523, 338962 V96300573, 33300476 H47600122, 338962 V96300111, 338962 V96300813, 338962 V96300101, 338962 V96301041, 342973 E97300446, 338962 V96301154, 338960 V96101418, 34302008 E1071, 343022 E0016, 654900 V96300310, 340551 H47100039, 340551 H47100049, 338962 V96300215, 340551 H47100072, 450500 D0893-2044, 342975 E97500691, 338960 V96100523, 338962 V96300456, 338962 V96300455, 450500 D08932046, 340551 H47100158, 342973 E97300322, 450500 D08932050, 342975 E97501110, 338962 V96300636, 338962 V96300637, 33300476 H47600124, 338962 V96300798, 338962 V96300799, 338962 V96300800, 648063 H06300005, 340551 H55100010, 340551 H55100013, 334225 W0089, 338962 V96301107, 338962 V96301186, 340551 H55100031, 340551 H55100032, 338962 V96301273, 647793 H64779300009, 647793 H64779300010, 338960 V33896101614, 343202 E0525, 343202 E0811, 343202 E1247, 343202 E1332, 338960 V96100965, 338960 V96101169, 338962 V96300206, 338962 V96300976, 335223 P22300091, 450500 D0869-2035, 643187 P18700003, 643695 P69500044, 338962 V96300650, 338962 V96300655, 641250 EP00000-PRE02, 641764 1201-46196-A054, 335223 P0327, 335223 P22300021, 335223 P22300029, 335223 P22300049, 333999 P99900026, 335223 PILOT2, 334079 PROTO3, 334078 P07800200, 643180 P18000014, 645054 P18200004, 643188 P18200005, 643188 P18800003, 643188 P18800005, 643188 P18800010, 643188 P18800017, 642942 P94200001, 648282 P28200198, 643188 P69500001, 340469 P46900033, 334225 A002, 334225 A003, 334225 PILOT010, 340128 PILOT015, 334225 PILOT019, 334225 W0031, 340128 W91100026, 340128 W91100174, 340128 W91100179, 340128 W91100228, 344860 W91100063, 343020 E0001, 343020 E0061, 343020 E0073, 343020 E0344, 343020 E0534, 343020 E0612, 343020 E3717, 343276 AP2, 343202 E0158, 34327608 E1245, 343202 E20200062, 343202 E2591, 34327608 E6104, 342975 E97500688, 343023 E0634, 343023 E0914, 343277 E1121, 343023 E2430, 337175 V0002, 337175 V0005, 336036 V0006, 336036 V0018, 335860 V0116, 335860 V03600034, 337175 V07300209, 337175 V07300226, 337175 V07300232, 337175 V07300255, 337175 V07300262, 337175 V07300320, 337175 V07300362, 337175 V07300365, 337175 V07300425, 641548 V07300503, 338962 V33896300003, 339473 V87500078, 338960 V96100138, 338960 V96100201, 338960 V96101149, 338962 V96300005, 338962 V96300013, 338962 V96300017, 338962 V96300018, 338962 V96300019, 338962 V96300033, 338962 V96300034, 338962 V96300037, 338962 V96300242, 338962 V96300291, 338962 V96301134, 338962 V96301195, 338962 V96301211, 34008860 D0004, 34008860 D0014, 343186 D0015, 343073 D0066, 343186 D0245R, 34008861 D0408, 34008860 D0409, 343073 D0596, 343073 D0894, 343073 D290200026, 343073 D290200027, 337858 D858000406, 337858 D858000432, 337858 D858000474, 337858 D858000475, 337858 D858000571, 337858 D858000918, 337858 D858001010, 337858 D858001753, 343268 SE0360, 646500 X5000041, 644655 Z65500004, 649225A1 Z5A100001, 649225A1 Z5A100002, 649225A1 Z5A100003, 649225A1 Z5A100005, 647177 H17700004, 647794 H5S100001, 647783 H5S100002, 333004 H1031, 339101 H1031R, 333004 H1059, 333004 H1167, 34862708 H47200099, 33300476 H47600061, 33300482 H48200035, 33300408 H48200052, 339101 H47100215, 641764 1001-37595-A033-R005, 641764 1001-6997-A061, 641764 1001-15897-A064, 641764 1001-6997-A062, 641250 EP00118, 641764 1001-37397-A072, 641250 EP00121, 641764 1001-4007-7326, 641764 1001-37397-A071, 641764 1001-96696-A059, 641764 1001-56897-A077, 641764 1001-68096-A056, 641764 1001-56897-A076, 641250 EP00128, 641250 EP00127, 641764 1001-56897-A094, 641764 1001-56897-A092, 641250 EP00136, 641250 EP00137, 641764 1001-17797-A065, 641764 1001-17398-A100, 641250 EP00141, 641764 1001-45198-A102, 641764 1001-96197-A087, 641250 EP00143, 641764 1001-85198-A111, 641250 EP00107, 641250 EP00145, 641250 EP00138, 641250 Y250EP146, 645569 Y569P020, 641764 1001-106395-A044, 641250 EP00149, 645569 Y569P017, 641250 Y250EP151, 641250 Y250EP157, 641764 Y764EP127, 641250 Y250EP160, 641250 EP118, 641250 EP00158, 641764 1001-6899-A118, 641764 Y764P138, 641764 Y764P141, 641764 1001-75997-A083, 641764 1001-95695-A040, 641250 EP00133, 641250 EP002, 641250 EP0112, 641250 EP0125, 641250 PP4, 641250 PRE-03, 641764 1001-105192-7323, 641764 1001-25095-A028, 641764 1001-25694-A017, 641764 1001-36195-A031, 641764 1001-56797-A075, 641764 1001-65093-7330, 641764 1001-66793-7331, 641764 1001-6695-A024, 641764 1001-75493-7328, 641764 1001-75997-A081, 641764 1001-97995-A042, 641764 Y764P115, 340551 H47100032, 338960 V96100238, 343276 E1051, 338960 V96100326, 340551 H47100069, 340469 P46900079, 340469 P46900086, 340551 H47100088, 334079 P07900215, 338960 V96100611, 339473 V87500065, 64355401 V96100133, 643178 P17800028, 340551 H47100225, 340551 H47100227, 342975 E97501264, 339101 H47100166, 342975 E97501404, 33300482 H46200074, 339473 V87500099, 338960 V96101213, 338960 V96101215, 338962 V96301031, 648282 P28200048, 649225 H5B400025, 648282 P28200111, 649225 H5B500011, 338962 V96300198, 338960 V96101493, 338962 V96301208, 649225 H5B500025, 335223 P22300080, 343020 E0148, 343020 E0367, 343020 E0407, 343020 E3401, 343022 E0951, 343020 E0067, 343202 E0817, 343023 E0861, 335860 V03600023, 338960 V96100001, 338962 V96300014, 641548 V96300989, 338962 V96301099, 338960 V96100164, 340469 P46900048, 339101 H1138, 340469 P46900072, 340469 P46900101, 338962 V96300368, 340551 H47100107, 342976 E97600173, 342973 E97300314, 340551 H47100199, 338960 V96101051, 342973 E97300389, 343276 E97501139, 338962 V96300777, 647793 H79300003, 649225 H5B400032, 649225 H5B400051, 648282 P64828200004, 645054 P0238, 338960 V96100731, 343276 E3461, 342973 E97300355, 342973 E97300350, 338962 V96300897, 338962 V96300035, 338960 V96101452, 338962 V96300325, 338962 V96300236, 338962 V96301290, 338962 V96301294, 641250 EP00161, 338962 V33896301386, 338962 V33896301393, 343276 E0955, 641764 1001-107196-A001, 343023 E0770, 342973 E97300140, 340128 W91100187, 343276 E2481, 33300472 H47200092, 338960 V96100459, 338962 V96300436, 342975 E97501056, 338962 V96300634, 340551 H47100214, 643695 P69500078, 340128 W91100280, 340551 H47100220, 338960 V96100944, 643695 P69500088, 338960 V96100982, 338962 V96300293, 343276 E5698, 643695 P69500127, 647780 H78000003, 649225 H5B400010, 647800 H80000007, 340128 W91100307, 649225 H5B700003, 649225 H5B400017, 647177 H17700030, 649225 H5B400042, 650110 P11000024, 342976 E97600384, 647794 H6477940000022, 338962 V33896301378, 649225 H649225B1013, 650110 P65011000035, 343020 E02000099, 343202 E0802, 343202 E0837, 343202 E2379, 342975 E97500563, 338960 V96100231, 338960 V96100785, 643695 P69500054, 338962 V96300568, 338960 V96100957, 643182 P18200025, 643177 P17700036, 338960 V96100895, 338962 V96300717, 338960 V96100979, 643695 P69500096, 338962 V96300963, 643178 P17800069, 648282 P28200002, 645054 P0164, 338960 V96101551, 338960 V96101552, 648282 P64828200007, 338960 V96100665, 337858 D858001259, 343276 E3954, 343202 E0745, 33717508 V07300599, 33717508 V07300605, 641548 V07300607, 342975 E97500507, 338962 V96300241, 338962 V96300318, 342976 E97600153, 338962 V96300480, 343276 E2096, 338962 V96300572, 338962 V96300607, 338960 V96100937, 338960 V96101120, 338960 V96101127, 338960 V96101128, 338960 V96101129, 338960 V96101168, 338962 V96300918, 343276 E3237, 649225 H5B500003, 342973 E97300475, 338962 V96301269, 338960 V96101544, 343202 E0686, 343202 E2677, 34327608 E3511, 343023 E0787, 343023 E0789, 338960 V96101124, 33896008 V96101344, 338960 V96101404, 34008860 D0238, 34008860 D0252, 337858 D858002003, 338960 V96100183, 340551 H47100041, 338962 V96300279, 338962 V96300317, 338962 V96300351, 338960 V96100615, 340551 H47100120, 340551 H47100117, 340551 H47100131, 340551 H47100161, 340551 H47100178, 338960 V96100800, 340551 H47100217, 337858 D858001565, 342975 E97501188, 338962 V96300610, 342975 E97501266, 340551 H55100004, 647799 H79900001, 647177 H17700006, 647177 H17700012, 340551 H55100022, 338960 V96101326, 649225 H5B400050, 647794 H79400017, 338962 V33896301337, 649225 H649225B9001, 334225 PILOT007, 343202 E0957, 343202 E2730, 343023 E1122, 34008860 D0172, 34008860 D0249, 343073 D0847, 450500 D08932048, 342975 E97500602, 342973 E97300179, 338960 V96100336, 338960 V96100377, 342975 E97500689, 338960 V96100431, 338960 V96100557, 338960 V96100575, 342975 E97500875, 342975 E97500877, 338960 V96100675, 339473 V87500069, 338960 V96100771, 342975 E97501200, 338960 V96100970, 338962 V96300617, 342975 E97501303, 338960 V96101265, 338962 V96301086, 342975 E97501595, 343276 E5542, 338960 V96101538, 342975 E97501755, 342975 E97501757, 338962 V33896301394, 343020 E0263, 343022 E0691, 343202 E1215, and 343023 E1007.

Hematology and Pathology Devices

2

No

Nationwide Distribution

BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway 855, BD Pathway 435 and all SORP instruments. || BD Biosciences Flow cytometers for the enumeration of tissue and biological fluid samples such as blood and blood components.

All lots from S15007 to S15026 inclusive and All lots from T15037A to T15076A inclusive.

Hematology and Pathology Devices

2

No

Worldwide Distribution - US (nationwide) and Internationally to China, Lebanon, Costa Rica, Singapore, Brazil, Jordan, Russia, Greece, Austria, India, Nigeria, United Kingdom, Korea, Saudi Arabia, Morocco, Slovenia, Portugal, Tunisia, Kazakhstn, Qatar, U.A.E. Israel, Taiwan, Mexico, Argentina, Poland, Italy, Hong Kong, Kuwait, Switzerland, Turkey, Ireland, Chile, Germany, and Australia.

i-Stat PT/INR Cartridges || List number 03P89-24 || The cartridges are packaged in sealed pouches, one per pouch. There are 24 cartridges packed in a box. || a prothrombin time test useful in monitoring patients receiving oral anticoagulation therapy such as coumadin or warfarin.

Part Number 7900001, Kit Lot Number 0074B Exp Date 2015-10-08, Kit Lot Number 0094B Exp Date 2015-12-12

Hematology and Pathology Devices

2

No

Nationwide Distribution.

Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.

Catalog number 335809; Lot numbers 4300708, 4304864, 5013643; all with expiry dates of 31 OCT 2015

Hematology and Pathology Devices

1

No

US Distribution and Internationally to Taiwan.

BD CD56 PE Cy 7: NCAM16.2 ASR || Analyte Specific Reagent, Catalog number 335809 || Hematology: || The CD 56 antigen promotes homophilic adhesion in neurons and may be involved in homophilic adhesion of NK cells.

Lot Numbers: 510376F-510657F, M405229-M503553.

Hematology and Pathology Devices

1

No

Distributed US (nationwide) including Puerto Rico and U.S. Virgin Islands and the countries of Bermuda, Canada, Guatemala, Hong Kong, Mexico, Panama, Taiwan, and Trinidad-Tobago.

COULTER LH Series Diluent, Catalog No. 8547194, Product Labeling A40192-AD. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types, such as red blood cells and platelets.

Lot Numbers: 18203F-18206F.

Hematology and Pathology Devices

1

No

Distributed US (nationwide) including Puerto Rico and U.S. Virgin Islands and the countries of Bermuda, Canada, Guatemala, Hong Kong, Mexico, Panama, Taiwan, and Trinidad-Tobago.

COULTER ISOTON 4 Diluent, Catalog No. 8547148. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types, such as red blood cells and platelets.

Product Code: Leica ASP6025   Serial Numbers: 163, 169, 200-729, 731, 733, 735, 737, 739, 741, 743, 745, 747, 749, 751, 753, 755, 757, 759, 761, 763, 765, 767, 769, 771, 773, 775, 777, 779, 781, 783, 785, 787, 789, 791, 793, 795, 797, 799, 801, 803, 805, 807, 809, 811.

Hematology and Pathology Devices

1

No

Worldwide Distribution - US including AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH,PA, SC, TN, TX, VA, WA, WI, WV and District of Columbia. Foreign distribution to United Arab Emirates, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Colombia, Czech Republic , Germany, Spain, France, England, Georgia, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, Korea, Kuwait, Lithuania, Myanmar, Mexico, Malaysia, Netherland, Norway, Peru, Philippines, Poland, Qatar, Reunion, Romania, Serbia, Saudi Arabia, Singapore, Slovenia, Thailand, Turkey, Taiwan, and South Africa.

The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. || The Leica ASP6025 Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.

Lot: 505801 Expiration date: 2015-11 catalog numbers: G7583-CTL 7-G7583-CTL-L1 7-G7583-CTL-L2 7-G7583-CTL-L3

Hematology and Pathology Devices

2

No

Worldwide distribution: US (nationwide) including states of: PA, CA, KY, FL, NJ, DE, MI, MN,and IL; and countries of: United Arab Emirates, Austria, Italy, Israel, Greece, and Australia.

Pointe Scientific G6PD Controls || Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). || Also sold as individual vials || Bottle: Clear glass vials || Cap: Rubber seal with colored aluminum seals || Glucose-6-phosphate dehydrogenase (G6PD) controls can be used to test for the quantitative and qualitative determination of G6PD in blood.

Catalog Number 340133; lot # 5112711, Expiration date: 30 Nov 2016.

Hematology and Pathology Devices

2

No

Worldwide Distribution. US nationwide (TX, CA, NC, OH, SD, PA, CT, UT, MD, TX, GA), Argentina, Taiwan, Australia, Japan, China, New Zealand, Chile and Colombia.

CD4 (SK3), FITC; || Contains CD4 FITC with gelatin and 0.1% sodium Azide. || Catalog number 340133 || in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell surface receptor expressed by a majority of thymocytes, a subpopulation of mature T helper cells, and at low levels on monocytes. CD4 is a receptor for the human immunodeficiency virus (HIV).

Lot 15180, 15286, 15287, 15300, 15305

Hematology and Pathology Devices

1

No

Distributed in the states of CA, KY, MD, GA, and IL.

ABG-HM-1 Hummi Micro Draw Blood Transfer Device || Product Usage: || It is used for blood transfer and collection from Peripheral Arterial Line Catheters.

Lot Numbers: 405131002, 405173002, 405187002, 405208002, 405229002 405278002, 405292002

Hematology and Pathology Devices

2

No

Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.

Siemens Acute Care DDMR TestPak || Catalog Number: CDDMRE || SMN: 10701511 || in vitro diagnostic