FDAFDA · Food and drugs·Recall number Z-1931-2015
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.
Published July 8, 2015 · Recall initiated: May 7, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Distributor
- US (nationwide) including PR.
- Lot
- Catalog Numbers:04657608190; 03183807190; 05171857190; 03183807190; 11875426216; 11929429216; 11929437216.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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