Creatinine Plus. Intended for use on Hitachi/MODULAR 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 reagent used on Hitachi/MODULAR systems for measuring creatinine levels in serum, plasma, and urine. The recall affects 6,255 analytical units distributed nationwide in the US and Puerto Rico under catalog numbers 11775685216, 11875566216, and 11875582216.
The product poses a risk of drug interference when used with certain Cobas Analyzers. Test results may be falsely decreased when analyzing urine samples or blood samples taken before adequate time has passed following administration of Acetaminophen or N-acetylcysteine. The source does not specify a remedy 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: 6,255 analytical units distributed Lot/code info: Catalog Numbers: 11775685216; 11875566216; 11875582216.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.