Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitachi systems for The quantitative determination of total cholesterol in serum and plasma.
Check against the official notice below — it lists the full affected range.
Roche Diagnostics Operations, Inc. is recalling its Cholesterol CHOD-PAP in vitro diagnostic reagent system used on Hitachi systems for measuring total cholesterol in serum. The recall affects 6,255 analytical units distributed nationwide in the US and Puerto Rico under catalog numbers 11491458216, 11875540216, and 11875523216.
The recall was issued due to possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Test results may be falsely decreased when urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected too soon after administration of Acetaminophen or N-acetylcysteine are tested. 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: 6,255 analytical units distributed Lot/code info: Catalog Numbers: 11491458216; 11875540216; 11875523216.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.