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Devices
Device Recall Uric Acid plus ver.2
Model / Serial
Catalog Numbers:04657608190; 03183807190; 05171857190; 03183807190; 11875426216; 11929429216; 11929437216.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
US (nationwide) including PR.
Product Description
Uric Acid plus ver.2 || In vitro test for the quantitative determination of uric acid in human serum, plasma and urine or Roche/Hitachi MODULAR systems, cobas c111, COBAS Integra 800 and 400 plus systems, and cobas c systems.
Manufacturer
Roche Diagnostics Operations, Inc.
1 Event
Recall of Device Recall Uric Acid plus ver.2
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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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