Devices

Device Recall Lactate Dehydrogenase IFCC

Model / Serial
Catalog Numbers: 11822837190; 05401666190; 03183700190; 05171881190; 03183700190.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
US (nationwide) including PR.
Product Description
Lactate. || Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems for the quantitative determination of lactate concentration in plasm and cerebrospinal fluid.
Manufacturer
Roche Diagnostics Operations, Inc.
1 Event
- Recall of Device Recall Lactate Dehydrogenase IFCC

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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