Triglycerides GPO. In vitro test for the quantitative determination of triglycerides in human serum and plasma on the COBAS Integra 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems.
Check against the official notice below — it lists the full affected range.
Roche Diagnostics Operations, Inc. is recalling Triglycerides GPO, an in vitro test used with COBAS Integra 800 and 400 plus analyzer systems to measure triglyceride levels in human serum and plasma. The recall affects 6,255 units distributed nationwide in the United States and Puerto Rico across eight specific lot/catalog numbers.
The recall was initiated due to possible drug interference with the Trinder reaction method used in these tests. Test results may be falsely decreased when urine samples are tested using the Creatinine plus and Uric Acid applications, or when blood samples are collected before sufficient time has passed following administration of 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: 04657594190; 20767107322; 05171407190; 20767107322; 11730711216; 11876023216; 11876040216; 11488872216.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.