UDI 04015630972296, Lot Number: Y15133

Hematology and Pathology Devices

1

No

Worldwide distribution, including US nationwide, Argentina, Australia, Hong Kong, Indonesia, Philippines, Brazil, Chile, Thailand, Korea, Malaysia, New Zealand, Ecuador, Mexico, Pakistan, Vietnam, Germany, Japan, India, Colombia, Singapore, Uruguay, Peru, Canada, Taiwan, China,

ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 in vitro diagnostic

UDI 04015630970384, Lot Number: Y15146

Hematology and Pathology Devices

1

No

Worldwide distribution, including US nationwide, Argentina, Australia, Hong Kong, Indonesia, Philippines, Brazil, Chile, Thailand, Korea, Malaysia, New Zealand, Ecuador, Mexico, Pakistan, Vietnam, Germany, Japan, India, Colombia, Singapore, Uruguay, Peru, Canada, Taiwan, China,

ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001 in vitro diagnostic

UDI 04015630972807, Lot Numbers: Y14122, Y18107

Hematology and Pathology Devices

1

No

Worldwide distribution, including US nationwide, Argentina, Australia, Hong Kong, Indonesia, Philippines, Brazil, Chile, Thailand, Korea, Malaysia, New Zealand, Ecuador, Mexico, Pakistan, Vietnam, Germany, Japan, India, Colombia, Singapore, Uruguay, Peru, Canada, Taiwan, China,

CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001 in vitro diagnostic

UDI 04015630976287, Lot Numbers: Y22162, Y15546

Hematology and Pathology Devices

1

No

Worldwide distribution, including US nationwide, Argentina, Australia, Hong Kong, Indonesia, Philippines, Brazil, Chile, Thailand, Korea, Malaysia, New Zealand, Ecuador, Mexico, Pakistan, Vietnam, Germany, Japan, India, Colombia, Singapore, Uruguay, Peru, Canada, Taiwan, China,

CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic

UDI 04015630983834, Lot Numbers: Y15435, Y19322, Y22447

Hematology and Pathology Devices

1

No

Worldwide distribution, including US nationwide, Argentina, Australia, Hong Kong, Indonesia, Philippines, Brazil, Chile, Thailand, Korea, Malaysia, New Zealand, Ecuador, Mexico, Pakistan, Vietnam, Germany, Japan, India, Colombia, Singapore, Uruguay, Peru, Canada, Taiwan, China,

OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 06396518001 in vitro diagnostic

UDI 04015630984749, Lot Numbers: Y19318

Hematology and Pathology Devices

1

No

Worldwide distribution, including US nationwide, Argentina, Australia, Hong Kong, Indonesia, Philippines, Brazil, Chile, Thailand, Korea, Malaysia, New Zealand, Ecuador, Mexico, Pakistan, Vietnam, Germany, Japan, India, Colombia, Singapore, Uruguay, Peru, Canada, Taiwan, China,

OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI 06718663001 in vitro diagnostic

UDI 04015630972135, Lot Numbers: Y10759, Y17402, Y21312, Y13938, Y17403, Y22561

Hematology and Pathology Devices

1

No

Worldwide distribution, including US nationwide, Argentina, Australia, Hong Kong, Indonesia, Philippines, Brazil, Chile, Thailand, Korea, Malaysia, New Zealand, Ecuador, Mexico, Pakistan, Vietnam, Germany, Japan, India, Colombia, Singapore, Uruguay, Peru, Canada, Taiwan, China,

Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic

UDI 04015630972135, Lot Number: Y17990

Hematology and Pathology Devices

1

No

Worldwide distribution, including US nationwide, Argentina, Australia, Hong Kong, Indonesia, Philippines, Brazil, Chile, Thailand, Korea, Malaysia, New Zealand, Ecuador, Mexico, Pakistan, Vietnam, Germany, Japan, India, Colombia, Singapore, Uruguay, Peru, Canada, Taiwan, China,

ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in vitro diagnostic

UDI 04015630970254, Lot Number: Y15392

Hematology and Pathology Devices

1

No

Worldwide distribution, including US nationwide, Argentina, Australia, Hong Kong, Indonesia, Philippines, Brazil, Chile, Thailand, Korea, Malaysia, New Zealand, Ecuador, Mexico, Pakistan, Vietnam, Germany, Japan, India, Colombia, Singapore, Uruguay, Peru, Canada, Taiwan, China,

NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic

(1) 105-005405-00 (2 x 5.5L container) Lot Numbers: 2017060906, 2017041207, 2017042707, 2017041104, 2016122301, 2016112901, 2016060401, 2016052701, 2016052101, 2016050301; (2)105-005406-00 (20L container) Lot Numbers: 2017041104, 2016121901, 2016051801, 2016050301

Hematology and Pathology Devices

1

No

US Distribution including Puerto Rico and to the states of : CA, MI, NC, TX, and WA. .

Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer; Part Numbers: (1) 105-005405-00 (2 x 5.5L container), (2) 105-005406-00 (20L container) || The M-30D Diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells. It is for use with the Mindray BC-3200 and BC-3600 Hematology Analyzer.

Lot Numbers: 2017060105 ¿ 2017041106 ¿ 2017010701 ¿ 2016121401 ¿ 2016112301 ¿ 2016111302

Hematology and Pathology Devices

1

No

US Distribution including Puerto Rico and to the states of : CA, MI, NC, TX, and WA. .

Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: 105-007867-00 (20L container) || The M-53D diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells. It is for use with the Mindray BC-5390 Hematology Analyzer.

All since 08/20/2014

Hematology and Pathology Devices

1

No

Distributed to accounts in 8 states: CA, FL, NJ, NY, OR, PA, VA, and WI. International distribution to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Europe, Hong Kong, Japan, Singapore, Taiwan, and Thailand.

BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829

All since 08/20/2014

Hematology and Pathology Devices

1

No

Distributed to accounts in 8 states: CA, FL, NJ, NY, OR, PA, VA, and WI. International distribution to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Europe, Hong Kong, Japan, Singapore, Taiwan, and Thailand.

BD MAX DNA MMK Lab Use, catalog no. 442828

Lot #7212154 A

Hematology and Pathology Devices

1

No

Worldwide Distribution and US Nationwide Distribution

iChem VELOCITY Urine Chemistry Strips, REF 800-7212 || Product Usage: || The iChem VELOCITY automated urine chemistry system is an in vitro diagnostic deice used to automate the urine chemistry analysis profile using iChem VELOCITY Urine Chemistry Strips. The iChem VELOCITY can be used as a stand alone-system, as well as in an iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semi- quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones, and ascorbic acid; and qualitative results for nitrites, color, and clarity. iChem VELOCITY strips are intended for use with the iCHEM VELOCITY analyzer. In particular they are not intended for visual reading. The iChem VELOCITY test strips are not intended for visual reading. The iChem VELOCITY is not intended to be used as a Point of Care (POC) analyzer. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iCHEM VELOCITY are intended for clinical laboratory use and in vitro diagnostic use only.

Reagents for use with the PREVI¿ Color Gram:  IODINE-B (ref: 29523) Lot number: G59407 Exp. 15-Aug-18 CRYSTAL VIOLET-C (ref: 29524) Lot number: G52306 Exp.19-Jul-18 FUCHSIN-A (ref: 29522): Lot Number Lot number: F89544 Exp. 13-Apr-18

Hematology and Pathology Devices

1

No

International distribution.

The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to stain bacterial and fungal microorganisms for direct examination, according to Gram s method. || The PREVI¿ Color Gram instrument sprays the PREVI¿ Color Gram reagents onto microscope slides which have been smeared with specimens to be examined. The staining procedure is rapid and precise. Each reagent has a specific position (A, B, C, D, E) on the PREVI¿ Color Gram platform that is also indicated on the reagent label. || An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.

Color Gram 2 (COLOR GRAM 2 - F) (ref: 55542) Lot number G64508

Hematology and Pathology Devices

1

No

International distribution.

Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal microorganisms for direct examination, according to the Gram method. || Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Lot Numbers: 4392, 4492, 4592, 4692, 4792, 4892, 4992, 5092, 5192, 5292, and 0293

Hematology and Pathology Devices

1

No

Nationwide

ThinPrep Microscope Slides for Non-Gynecologic Use || Size 1'' x 3'' || Reorder Number: 70214-001

Item Nos. 7062X/75, 7062X/85, and 7062X/86. Lot #2255 Exp. Date September 30, 2004

Hematology and Pathology Devices

1

No

The Ethanol Products were distributed nationwide by the following distributors: VWR International, 1310 Goshen Pkwy, West Chester, PA 19380; Government Scientific, 8460 K-Tyco Road, Vienna, VA 22182; Allegiance Healthcare, 1430 Waukegan Rd., McGaw Park, IL 60085; Fisher Scientific, 2000 Park Lane, Pittsburgh, PA 15275; Hawaii Chemical Co., 2363 North King Street, Honolulu, HI 96819; Krackeler Scientific Inc., 57 Broadway, Albany, NY 12202; Midland Scientific Inc., 1202 South 11th St., Omaha, NE 68108; Reagents, Inc. 4746 Sweden Rd., Charlotte, NC 28224. The Papanicolaou Stain was distributed nationwide by the following distributors: VWR International, 1310 Goshen Pkwy, West Chester, PA 19380; Fisher Scientific, 2000 Park Lane, Pittsburgh, PA 15275; Kramer Scientific, 711 Executive Blvd, Valley Cottage, NY 10989; Laboratory Supply Company, 3069 Mercury Rd., Jacksonville, FL 32207; Allegiance Healthcare, 1430 Waukegan Rd., McGaw Park, IL 60085; Infolab, 3000 Greenhill Dr., Round Rock, TX 78664; Government Scientific, 8460 K-Tyco Road, Vienna, VA 22182.

Papanicolaou Stain EA-50. Product size configurations: 1L, 4L, and 10L. Item Nos. 7062X/75, 7062X/85, and 7062X/86.

Any instrument which is not equipped with v4.55 or above will be upgraded.

Hematology and Pathology Devices

1

No

Nationwide.

PENTRA 120 and PENTRA 120 Retic Hematology Analyzer

TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, Lot F10185; HBV Quantitation Standard (HBV QS) Lot F10513.

Hematology and Pathology Devices

1

No

One customers received 14 kits on 1/3/2005. This one customer was LabCorp, 1912 Alexander Drive, Research Triangle Park, NC 27709.

TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, containing HBV Quantitation Standard (HBV QS).

The following serial numbers of the Aperio ScanScope systems are affected in the USA by this recall:  ¿ScanScope XT ScanScope AT ScanScope ATT ScanScope es, esa  1223, 1273, 1278, 1277, 1282, 1593,1605, 1648,1657,1660, 5064,5068,5108,5155,5170,5171  1285,1286,1287,1293,1296, 1619, 1620, 1662,1663,1666, 5176,5181,5187,5196,5198,5202,  1299,1300,1301,1302,1304, 1623, 1633, 1671, 1672, 1673, 5204,5205,5233,5236,5237,5241,  1311,1312,1314,1315,1316, 1634,1635, 1676, 1678, 1679, 5244,5245,5246,5248,5253,5262,  1318,1319,1320,1321,1322, 1636, 1637, 1690, 1692, 1695, 5266,5267,5269,5270,5272,5276,  1324,1325,1327,1328,1330, 1638,1640, 1698,1700,1718 5277,5279,5283,5287,5288,5293,  1332, 1333, 1335, 1336, 1338, 1643,1645, 5294, 5295, 5302, 5307, 5308, 5309,  1339, 1340, 1342, 1343, 1345, 1649,1654, 5314,5315,5316,5317,5324,5327,  1350,1352,1357,1358,1359, 1656,1664, 5328,5329,5330,5331,5333,5334,  1366, 1368, 1369, 1370, 1372, 1686, 1687, 5336,5339,5340,5341,5345,5347,  1382,1383,1392,1394,1396, 1688, 1689, 5348,5352,5353,5356,5367,5371,  1397, 1399, 1400, 1402, 1404, 1696, 1699, 5374,5379,5381,5388,5390,5394,  1405,1407,1409,1410,1413, 1703,1705, 5396,5402,5403,5404,5405,5406,  1417,1418,1419,1420,1421, 1707, 1708, 5408,5409,5415,5416,5418,5419,  1422, 1423, 1424, 1425, 1426, 1709,1711, 5433,5440,5452,5456,5457,5459,  1436,1441,1442,1444,1445, 1714,1716, 5462,5465,5466,5467,5468,5469,  1446, 1448, 1449, 1450, 1452, 1719,1721, 5470,5473,5475,5476,5477,5478,  1453, 1454, 1456, 1457, 1458, 1723,1724, 5482,5485,5486,5489,5490,5492,  1460,1461,1466,1475,1476, 1725,1727, 5493,5504,5515,5516,5517,5518,  1481,1482,1486,1487,1490, 1728,1729, 5520, 5529, 5537, 5540, 5552, 5566,  1492, 1499, 1500, 1502, 1503, 1731,1733, 5567,5574,5578,5581,5587,5590,  1505,1506,1507,1508,1509, 1735, 1736, 5591,5592,5593  1511,1512,1514,1515,1516, 1739,1744  1517,1519,1520,1522,1523,  1525, 1527, 1528, 1532, 1534,  1535, 1536, 1537, 1538, 1540,  1542,1543,1544,1545,1546,  1547,1548,1549,1550,1551,  1552, 1553, 1554, 1556, 1557,  1559,1560,1563,1564,1569,  1570, 1571, 1575, 1576, 1582,  1586,1587,1588,1590,1591,  1596,1597,1611,1627

Hematology and Pathology Devices

1

No

Nationwide Distribution - including all states, none internationally .

Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. || Automated digital slide creation and viewing device. || It is intended to create and view electronic image files representative of tissue specimens fixed to glass slides.

PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 6605360R, 6605470, 6605470R All Software Versions

Hematology and Pathology Devices

1

No

Nationwide and Canada

COULTER GEN.S Series Hematology Analyzer, PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 6605360R, 6605470, 6605470R

Lot Numbers:  AR0820904  PU0820204,  PU0820305,  PU0820803F,  PU0820804

Hematology and Pathology Devices

1

No

Nationwide

BioGenex brand Hepatitis B Virus Core Antigen Antibody, Cat. No. AR082-5R and PU082-UP, || Product is distributed by BioGenex Laboratories, 4600 Norris Canyon Rd., San Ramon, CA 94583

Lot Numbers:  AM3640305,  AM3640404, AM3640406, AM3640505,  AM3640804, AM3640804X, MU3640305, MU3640504, MU3641004, MU3641005

Hematology and Pathology Devices

1

No

Nationwide

BioGenex brand Hepatitis B Virus Surface Antigen Antibody, Cat. No. AM364-5M and MU364-UC, || Product is distributed by BioGenex Laboratories, 4600 Norris Canyon Rd., San Ramon, CA 94583

Red Caps - Model #904-439  lot number less than 0535033

Hematology and Pathology Devices

1

No

Nationwide, Canada and Istanbul.

Capillary (end) caps, accessory for use with blood gas analyzers included in Radiometer''s CLINITUBES kits. The end caps are packaged in bags. These bags are placed in the capillary tube kit which also contains: capillary tubes, end caps, mixing wires, and a magnet. Each kit may contain 1 or 5 bags depending on the kit model. Each bag contains: 110 Green caps per bag and 160 Red caps per bag.