order number 32-190078, lots 42919, 45942, 53417, 57026, 59938, 60858

Hematology and Pathology Devices

Unclassified

No

Nationwide, Germany, Japan, Canada, Korea, India, Malaysia, Australia, Hong Kong, Chile & Singapore

Vysis LSI p16 (9p21)/CEP 9 (9p11-q11) Dual Color Probe Set; a locus specific identifier DNA probe consisting of a mixture of the LSI p16 probe labeled with a SpectrumOrange and the CEP 9 probe labeled with a SpectrumGreen fluorophore, accompanied with LSI/WCP Hybridization Buffer; 20 evaluations; Vysis Inc., Downers Grove, IL 60515; order number 32-190078

all units

Hematology and Pathology Devices

1

No

Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Columbia, Czech Republic, Egypt, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Korea, Malaysia, Norway, Russia, Saudi Arabia, Singapore, Switzerland and the United Kingdom.

VP 2000 Processor; an automated tissue stainer || 100 volt - part 30-144100 or list 2J11-60; || 117 volt - part 30-144101 or list 2J11-01, and part 30-102832 - processor only; || 230 volt - part 30-144102 or list 2J11-04, and part 30-102833 processor only. || Designed to automate and standardize slide specimen processing including deparafinization, FISH pretreatment and routine slide staining for the laboratory. The unit is preprogrammed to perform slide pretreatment protocols for FISH assays and can be programmed to perform routine histology/cytology slide staining or routine slide washing according to user requirements.

VIDAS D-Dimer Exclusion II (An in vitro medical device (IVD))Multiple lot numbers affectedARTG Number: 190015

Hematology and Pathology Devices

Reference 304551-01 - Lots 1001625210, Exp. date 8/8/20123; 1001715580, Exp. date 9/26/2013; 1001711530, Exp. date 9/11/2013; 1001789540, Exp. date 10/29/2013; 1001932680, Exp. date 12/12/2013

Hematology and Pathology Devices

2

No

AL, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MA, MI, MN, MO, MT, NE, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY

VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products in human plasma using the Enzyme Linked Fluorescent Assay technique. Also indicated for use in conjunction with clinical pretest probability assessment model to exclude DVT and PE disease.

Lot Numbers: WK0002A , WK0003A, WK0003B, WK0004A ,   WK0005A , WK0006A, WK0006AR, WK0006B, WK0006BR,   WK0007A, WK0008A, WK0009A, WK0010A ,WK0010B, 10WK000C, WK0011A, WK0012A and WK0013A

Hematology and Pathology Devices

2

No

Worldwide Distribution- USA, and countries of Australia, Canada, France, Germany, Italy, Japan, Korea, Malaysia, Netherlands, New Zealand, Norway, Poland, Singapore, Spain, Sweden, Switzerland, & United Kingdom

VerifyNow P2Y12 Assay Device Kit, Part Number 85054

Assay Device Lot WD0034, Kit Lots W17105, W17140.

Hematology and Pathology Devices

2

No

Nationwide.

VerifyNow Asprin Assay Kit || Part No. 85034

lot number G-13850

Hematology and Pathology Devices

2

No

CA, FL, IL, LA, NH, NV, NY, OK, WA

Accumetrics part number 29001 VerifyNow Instrument, printe power supply

Ref 7900001, Lot 0036 Ref 7900000, Lot 0036A - This is a research use only lot and not for in vitro diagnostic use.

Hematology and Pathology Devices

2

No

The kits were distributed to hospitals and laboratories nationwide. They were also sent to 7 J&J; affiliated companies in France, Japan, Canada, England, Germany, Italy and Spain.

Cell Search Circulating Tumor Cell Kit (Epithelial) || Veridex LLC, a Johnson & Johnson Company || IVD || Veridex, LLC || 33 Technology Drive || Warren, NJ 07059 USA || 1-877-VERIDEX USA

Hematology and Pathology Devices

In-vitro diagnostics

Serial Numbers: 910006-910011, 910013-910016, 910019, 910020, 910022, 910023, 910029, 910031-910033, 910036, 910049, 910053, 910054, 910056, 910057, and 910060.

Hematology and Pathology Devices

1

No

Worldwide: USA, Japan and France

Ventana Medical System's Symphony Staining System, KPA, Model #: 2200000, Catalog #: 900-SYM1 & 900-SYM3, Ventana Medical Systems, Tucson, AZ

Model number: 270-0005; Lot number AA10686. expiry 3/31/13.

Hematology and Pathology Devices

2

No

Nationwide and to New Zealand, Canada, France, England, China, India, Mexico, Italy, Brazil, Australia, Singapore, Thailand, SriLanka, hong Kong, Sweden, Germany, Peru, Jamaica, Uruguay, Columbia, Argentina, Chile, Paraguay and Korea.

VARIANT / VARIANT II B-thalassemia Short Program Elution Buffer 2,. || Made in United States. || Bio-Rad Laboratories, Hercules, CA 94547. || Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

Resin Update CD-ROM, 250-3020 lot # AA 00092 goes with Reorder Pack Lot No. 50392618 Resin Update CD-ROM, 250-3020 lot # BA 00092 goes with Reorder Pack Lot No 50300210.  Resin Update CD-ROM, 250-3020 lot # CA 00092  Reorder Pack Lot No 50300645 & 50300650. Expiration date: 05/31/2011, 06/30/2011, 08/31/2011 PIN No. 250-3000;

Hematology and Pathology Devices

2

No

Worldwide Distribution -- USA , Brazil, Canada, Caribbean, France, Italy, and United Kingdom.

VARIANT nbs Sickle Program Resin Update CD-ROM; Model Number:250-3020, included in 250-3000; Distributed and Manufactured by Bio-Rad Laboratories, Inc. The VARIANT nbs Sickle Cell Program is intended as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper by high-performance liquid chromatography(HPLC). The VARIANT nbs Sickle Cell Program is intended for Professional use only.

Catalog number 270-0500, lot numbers 70000349, 70000353, both with expiration dates of 6/30/2011, which contains ROM Card Lot # LA82418 (Catalog # 270-0507). Rom Card is included in kit Lot number 70000349 and 70000353.

Hematology and Pathology Devices

2

No

Worldwide distribution: USA including: MD, NJ and UT; and countries of: Italy and Singapore.

The VARIANT Sickle Cell Short Program ROM Card; Distributed by and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA || The VARIANT Sickle Cell Short Program is designed as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper by high-performance liquid chromatography. For in vitro diagnostic use.

Model number: 270-2716; Lot number 70210702, 9/30/11. Contains Buffer lot number GA10429/GA10430, expiry 2/28/12.

Hematology and Pathology Devices

2

No

Nationwide and to New Zealand, Canada, France, England, China, India, Mexico, Italy, Brazil, Australia, Singapore, Thailand, SriLanka, hong Kong, Sweden, Germany, Peru, Jamaica, Uruguay, Columbia, Argentina, Chile, Paraguay and Korea.

VARIANT II TURBO LINK Hemoglobin A1c Program Reorder Pack, 1600 tests. || For the determination of Hemoglobin A1c in human whole blood. || Contents: || 1. Elution Buffer A, 1 x 2500 mL Bis-Tris Phosphate Buffer || 2. Elution Buffer B, 1 x 2100 mL Bis-Tris Phosphate Buffer || 3. Wash/Diluent Solution, 1 x 2500 mL, Deionized water || 4. Cartridge set - 2 cations exchange Analytical Cartridges, 4 cation exchange guard cartridges || 5. CD-ROM 1, CD Rom with program parameters || 6. Calibrator/Diluent Set, 2 levels, 2 vials each of lyophilized human red blood cell hemolysate with preservative, 1 bottle of diluent, 100 mL deionized water. || 7. Whole Blood Primer, 6 x 1 mL, Lyophilized human red blood cell hemolysate with preservative || 8. Sample Vials, 2 x 100, Polypropylene vials with pierceable lids || 9. Instruction Manual. || Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC) || Made in United States. || Bio-Rad Laboratories, Hercules, CA 94547.

Model number: 270-2713; Lot number 70210661, 9/30/11. Contains Buffer lot number GA10429, expiry 2/28/12

Hematology and Pathology Devices

2

No

Nationwide and to New Zealand, Canada, France, England, China, India, Mexico, Italy, Brazil, Australia, Singapore, Thailand, SriLanka, hong Kong, Sweden, Germany, Peru, Jamaica, Uruguay, Columbia, Argentina, Chile, Paraguay and Korea.

VARIANT II TURBO LINK Hemoglobin A1c Program Buffer Set. || Made in United States. || Bio-Rad Laboratories, Hercules, CA 94547. || Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

Model Catalog: (Lot serial: )

Hematology and Pathology Devices

Variant II Turbo with CDM 3.6T System

Model Catalog: 270-2600 (Lot serial: all)

Hematology and Pathology Devices

Variant II turbo Hemoglobin System

Model number: 270-2415; Lot number 70211066, expiry 03/31/2012; Lot number 70211068, expiry 3/31/2012. Contains Buffer lot number: AA10758/AA10759, expiry 3/31/12.

Hematology and Pathology Devices

2

No

Nationwide and to New Zealand, Canada, France, England, China, India, Mexico, Italy, Brazil, Australia, Singapore, Thailand, SriLanka, hong Kong, Sweden, Germany, Peru, Jamaica, Uruguay, Columbia, Argentina, Chile, Paraguay and Korea.

VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 2000 tests, || IVD, Made in United States. || Kit contains: || 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer || 2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer || 3. Cartridge Set, 2 cation exchange analytical cartridges, 5 cation exchange Guard cartridges. || 4. CD-ROM 1 - CD Rom with program parameters || 5. Calibration/Diluent set - 2 levels, 3 vials each of lyophilized human red blood cell hemolysate with preservative, 1 bottle diluent, 100 mL deionized water. || 6. Whole Blood Primer, 6 x 1 mL, lyophilized human red blood cell hemolysate with preservative, || 7. Sample vials - 2 x 100, 1.5 mL polypropylene vials with pierceable caps. || 8. Instruction Manual. || Bio-Rad Laboratories, Hercules, CA 94547. || Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

Model number: 270-2417; Lot number 70211073, expiry 12/31/2011. Contains Buffer lot: AA10758/AA10759, expiry 12/31/11.

Hematology and Pathology Devices

2

No

Nationwide and to New Zealand, Canada, France, England, China, India, Mexico, Italy, Brazil, Australia, Singapore, Thailand, SriLanka, hong Kong, Sweden, Germany, Peru, Jamaica, Uruguay, Columbia, Argentina, Chile, Paraguay and Korea.

VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 1600 tests, || IVD, Made in United States. || Kit contains: || 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer || 2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer || 3. Cartridge Set, 2 cation exchange analytical cartridges, 4 cation exchange Guard cartridges. || 4. CD-ROM 1 - CD Rom with program parameters || 5. Calibration/Diluent set - 2 levels, 2 vial each of lyophilized human red blood cell hemolysate with preservative, 1 bottle diluent, 100 mL deionized water. || 6. Whole Blood Primer, 6 x 1 mL, lyophilized human red blood cell hemolysate with preservative, || 7. Sample vials - 2 x 100, 1.5 mL polypropylene vials with pierceable caps. || 8. Instruction Manual. || Bio-Rad Laboratories, Hercules, CA 94547. || Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

Model number: 270-2402; Lot number AA10759, expiry 3/31/12.

Hematology and Pathology Devices

2

No

Nationwide and to New Zealand, Canada, France, England, China, India, Mexico, Italy, Brazil, Australia, Singapore, Thailand, SriLanka, hong Kong, Sweden, Germany, Peru, Jamaica, Uruguay, Columbia, Argentina, Chile, Paraguay and Korea.

VARIANT II TURBO Hemoglobin A1c Program Buffer B, || Made in United States. || Bio-Rad Laboratories, Hercules, CA 94547. || Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

Lot No. 70291520.

Hematology and Pathology Devices

2

No

Worldwide Distribution -- USA, Hong Kong, and New Zealand.

Variant II Turbo Hemoglobin A1c Program, model number 270 2417, manufactured by Bio-Rad Laboratories, Inc, Hercules, CA. || Intended Use: For the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC).

Catalog number: 270-2103 (250 tests; Reorder pack lot number: 64005302, Expiration: 4/2015; Catalog number: 270-2154 (500 tests) Reorder pack lot number: 64005207, Expiration: 6/2015; 64004750, Expiration: 11/2015

Hematology and Pathology Devices

2

No

Worldwide Distrubution ; USA INCLUDING CA, NY, GA, NC, AL, NJ, CT, WA, NY, LA, Il, MA and Internationally to China, Australia, Canada, France, Great Britain, Hong Kong, Thailand, Singapore,and Brazil.

Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses the principals of high performance liquid chromatography (HPLC) for the separation and determination of normal and abnormal hemoglobin.

Catalog number: 270-2716: Lot 70211322; 70211432, 70211440; exp 3/31/2012

Hematology and Pathology Devices

2

No

Nationwide Distribution including MI, SC, OH, IL, MN, MD, VA, NY and WI.

VARIANT II Link Hemoglobin A1c Program Reorder Pack, || 1600 tests, IVD, For the determination of Hemoglobin A1c in human whole blood. || Contents: || Elution Buffer A , 1 x 2500 mL || Elution Buffer B, 1 x 2100 mL || Wash/Diluent Solution, 1 x 2500 mL || Cartridge Set || CD ROM - 1 || Calibrator/Diluent Set || Whole Blood Primer, 6 x 1 mL || Sample vials, 2 x 100 || Instruction Manual || Bio-Rad Laboratories, Inc., 400 Alfred nobel Drive, Hercules, CA 94547-1803. || Intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HLCP).

Model Catalog: 2702000 (Lot serial: ); Model Catalog: 2702019 (Lot serial: )

Hematology and Pathology Devices

Variant II Hemoglobin Testing System

Model number: 270-2154; Lot number 70210674, expiry 1/13/13. lot number 70210954, expiry 2/28/13. Both contain Buffer lot numbers AA10685/AA10686, expiry 3/31/13. Model number : 270-0002; Lot number 70010957, expiry 2/28/13. Contains Buffer lot numbers AA10685/AA10686, expiry 3/31/13.

Hematology and Pathology Devices

2

No

Nationwide and to New Zealand, Canada, France, England, China, India, Mexico, Italy, Brazil, Australia, Singapore, Thailand, SriLanka, hong Kong, Sweden, Germany, Peru, Jamaica, Uruguay, Columbia, Argentina, Chile, Paraguay and Korea.

VARIANT B-thalassemia Short Program Reorder Pack, 500 Tests, For the separation and determination of HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made in United States. || Contents: || 1. Elution Buffer 1, 3 x 1900 mL sodium phosphate buffer || 2. Elution Buffer 2, 2 x 1800 mL sodium phosphate buffer || 3. Wash/Diluent solution, 2 x 1800 mL deionized water || 4. Analytical cartridge, 1 cation exchange cartridge || 5. 1 Calibrator/Diluent set, 1 Lypholized human red blood cells hemolysate with preservative; deionized water with preservative || 6. 1 CD Rom - CD R with program parameters || 7 Sample vials, 100 x 1.5 mL. Sample vials with pierceable cap || 8. Whole Blood Primer, 10 x 1.0 mL (3), Lypholized human red blood cells hemolysate with preservative; || 9. Instruction Manual || Bio-Rad Laboratories, Hercules, CA 94547. || Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)