Roche Diagnostics Operations, Inc.: LDL-Cholesterol plus gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholestero

Is my product affected?

LDL-Cholesterol plus gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma.

• UPC 05401682190
• UPC 03038866322
• UPC 05171369190

Check against the official notice below — it lists the full affected range.

What happened

Roche Diagnostics Operations, Inc. is recalling the LDL-Cholesterol plus gen.2 and Boehringer Mannheim Direct LDL-Cholesterol test due to possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Test results may be falsely decreased when run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has passed after administration of Acetaminophen or N-acetylcysteine. The recall affects 6,255 units distributed nationwide across the United States and Puerto Rico under catalog numbers 05401682190, 03038866322, 05171369190, and 03038866322.

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.

Hazard

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.

Details from the source

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 05401682190; 03038866322; 05171369190; 03038866322.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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