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

Is my product affected?

LDL-Cholesterol 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 04714423190
• UPC 04711220190
• UPC 05230438190
• UPC 05230446190

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

What happened

Roche Diagnostics Operations, Inc. is recalling the LDL-Cholesterol gen.2 test kit (Boehringer Mannheim Direct LDL-Cholesterol test) used on Cobas Analyzers. The recall affects 6,255 units distributed nationwide in the US and Puerto Rico under catalog numbers 04714423190, 04711220190, 05230438190, and 05230446190.

The test kits may produce falsely decreased results when using the Trinder reaction method with urine samples (specifically Creatinine plus and Uric Acid applications) or blood samples taken before adequate time has passed following patient administration of Acetaminophen or N-acetylcysteine. The source document does not specify a remedy 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 04714423190; 04711220190; 05230438190; 05230446190.

Source

Official record: FDA (Device enforcement) ↗

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

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