Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems for the quantitative determination of lactate concentration in plasm and cerebrospinal fluid.
Check against the official notice below — it lists the full affected range.
Roche Diagnostics Operations, Inc. is recalling Lactate products intended for use on multiple Cobas Analyzer systems. The recall affects 6,255 units distributed nationwide throughout the United States and Puerto Rico. The recalled products are identified by specific catalog numbers: 11822837190, 05401666190, 03183700190, 05171881190, and 03183700190.
The recall was issued due to possible drug interference when using the Trinder reaction method. Test results may be falsely decreased when Trinder tests are run on urine samples (limited to Creatinine plus and Uric Acid applications) or blood samples collected before sufficient time has passed after patients received 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: 11822837190; 05401666190; 03183700190; 05171881190; 03183700190.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.