Devices

Device Recall Roche Diagnostics CREP2

Model / Serial
Lot 60064001.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
Roche Diagnostics CREP2, Creatinine Plus Ver. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03263991190. || An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of creatine in serum, urine and plasma.
Manufacturer
Roche Diagnostics Corp.
1 Event
- Recall of Device Recall Roche Diagnostics CREP2

Manufacturer

Roche Diagnostics Corp.

Manufacturer Address
Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
Source
USFDA

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