Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c 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. has recalled the COBAS Integra Cholesterol Gen.2 cassette, an in vitro diagnostic reagent system used on COBAS Integra 800 and 400 analyzers. The recall affects 6,255 analytical units distributed nationwide in the US and Puerto Rico. The problem involves possible drug interference when using the Trinder reaction method, which can cause falsely decreased test results when samples (either urine for Creatinine plus and Uric Acid applications, or blood) are collected before sufficient time has passed after a patient takes Acetaminophen or N-acetylcysteine.
The affected products are identified by the catalog numbers 04718917190, 03039773190, 05168538190, and 03039773190. 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: 04718917190; 03039773190; 05168538190; 03039773190.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.