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.
Check against the official notice below — it lists the full affected range.
Roche Diagnostics Operations, Inc. is recalling the Uric Acid plus ver.2 in vitro test used with Roche/Hitachi MODULAR systems and cobas analyzers. The recall affects 6,255 units distributed nationwide in the US and Puerto Rico across seven specific catalog numbers. The product uses a Trinder reaction method that may produce falsely decreased test results under certain conditions.
The recalled test can produce inaccurate results when used with urine samples (for Creatinine plus and Uric Acid applications) or blood samples collected before sufficient time has elapsed following administration of the drugs Acetaminophen or N-acetylcysteine. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US (nationwide) including PR. Quantity: 6255 Lot/code info: Catalog Numbers:04657608190; 03183807190; 05171857190; 03183807190; 11875426216; 11929429216; 11929437216.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.