Devices

Device Recall Cobas Homocysteine Enzymatic Assay

Model / Serial
05385415190, Homocysteine 100Tests, cobas c, COBAS INTEGRA Lot number 69781101
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
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.
Product Description
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.
Manufacturer
Roche Diagnostics Operations, Inc.
1 Event
- Recall of Device Recall Cobas Homocysteine Enzymatic Assay

Manufacturer

Roche Diagnostics Operations, Inc.

Manufacturer Address
Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
Manufacturer Parent Company (2017)
Roche Holding AG
Source
USFDA

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