Device Recall COBAS

05385415190, Homocysteine 100Tests, cobas c, COBAS INTEGRA  Lot number 69781101

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution-including PR and the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MI, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, , SC, TN, TX, VA, WA, and WV.

Homocysteine test system - Homocysteine Reagent. || 05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA || Homocysteine Enzymatic Assay is an in vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems.

Production Identifier (Lot/Serial Number): M1-E-00375, M1-E-00380, M1-E-00381, M1-E-00382, M1-E-00389

Immunology and Microbiology Devices

2

No

US Distribution to the states of :TX and NC.

cobas Liat Analyzer, for in vitro diagnostic use.

Part numbers:05083435001 and 06268854001

Clinical Chemistry and Clinical Toxicology Devices

1

No

US Distribution including Puerto Rico and to the states of :TX, OH, TN, AZ, WA, MI and GA

cobas p 512 pre-analytical system || Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.

US-IVD: M1-E-00383 & M1-E-00434

Immunology and Microbiology Devices

2

No

Distributed in NC and WA.

cobas¿ Liat¿ Analyzer

Lot Numbers: 51222E, 60121H, 60201D, and 60229F

Immunology and Microbiology Devices

2

No

Distributed in the states of: TX, NY, OR, HI, MD, PA, NC, MA, IA, WA, OR, AK, ME, MN, VA, MT, PA, and LA.

cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.