HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of HDL-cholesterol concentration in serum and plasma.
Check against the official notice below — it lists the full affected range.
Roche Diagnostics Operations, Inc. is recalling HDL-Cholesterol plus gen.3. and Small Supersized test reagents intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems. The recall affects 6,255 units distributed nationwide in the US and Puerto Rico. The reagents use the Trinder reaction method, which can produce falsely decreased test results when analyzing urine samples (for Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has passed after a patient has taken Acetaminophen or N-acetylcysteine.
This drug interference means that patients who recently took these medications may receive inaccurate test results on affected analyzers. The specific lot/catalog numbers involved are 05401488190, 0439980319, 05168805190, 04399803190, and 04878205160. The source document does not specify a remedy or further 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: 05401488190; 0439980319; 05168805190; 04399803190, 04878205160.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.