Creatinine Plus ver. 2. Intended for use on COBAS INTEGRA systems , cobas c111, and cobas c systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.
Check against the official notice below — it lists the full affected range.
Roche Diagnostics Operations, Inc. is recalling Creatinine Plus ver. 2 reagent kits used on multiple Cobas analyzer systems. The recall affects 6,255 analytical units distributed nationwide in the United States and Puerto Rico. The kits are used to measure creatinine levels in patient samples.
The recall was initiated due to possible drug interference that can cause falsely decreased test results when samples are analyzed using the Trinder reaction method. This interference occurs specifically with urine samples tested using Creatinine Plus or Uric Acid applications, or with blood samples collected before sufficient time has passed after a patient received Acetaminophen or N-acetylcysteine. The source document does not specify what actions affected consumers should take in response to this recall.
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: 6,255 analytical units distributed Lot/code info: Catalog Numbers: 05401470190; 03263991190; 05168589190; 03263991190.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.