Roche Diagnostics Operations, Inc.: Triglycerides/Glycerol Blanked. In vitro test for the quantitative determination of triglycerides in human serum and plasma or Roche/Hitachi MODULAR systems, and co

Is my product affected?

Triglycerides/Glycerol Blanked. In vitro test for the quantitative determination of triglycerides in human serum and plasma or Roche/Hitachi MODULAR systems, and cobas c systems.

• UPC 11877771216
• UPC 11877780190
• UPC 11877798190
• UPC 05976006190

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

What happened

Roche Diagnostics Operations, Inc. is recalling triglyceride test kits used with Roche/Hitachi MODULAR and Cobas Analyzers distributed nationwide in the United States and Puerto Rico. The recall affects 6,255 units with catalog numbers 11877771216, 11877780190, 11877798190, and 05976006190.

The kits may produce falsely decreased test results when used with the Trinder reaction method on blood samples collected shortly after a patient has taken Acetaminophen or N-acetylcysteine, or when testing certain urine samples (Creatinine plus and Uric Acid applications only). This drug interference could lead to inaccurate measurements. The source document does not specify what action affected consumers should take.

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:11877771216; 11877780190; 11877798190; 05976006190.

Source

Official record: FDA (Device enforcement) ↗

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

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