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Devices
Device Recall Cobas c8000 Modular Analyzer Series Cobasc502
Model / Serial
not applicable
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
USA Nationwide Distribution including San Juan PR
Product Description
Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids.
Manufacturer
Roche Diagnostics Operations, Inc.
1 Event
Recall of Device Recall Cobas c8000 Modular Analyzer Series Cobasc502
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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
Language
English
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