FDAMay 7, 2015device
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.
Official recall recorded by the U.S. Food & Drug Administration.
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
FDA enforcement status: Terminated
Brands named
roche diagnostics operationsrocheroche diagnostics
UPCs
046576081900318380719005171857190118754262161192942921611929437216
Recall history
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