Roche Diagnostics Recalls Triglycerides/Glycerol Blanked In Vitro Test Kits
Roche Diagnostics is recalling 6,255 units of Triglycerides/Glycerol Blanked in vitro test kits due to possible drug interference that may cause falsely decreased results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential inaccurate test results due to drug interference, which is a significant quality issue but does not involve reported injuries, fatalities, or high-risk pathogens, fitting the Moderate severity criteria for labeling/quality errors without reported harm.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 6,255 units of the Triglycerides/Glycerol Blanked in vitro test. This test is used for the quantitative determination of triglycerides in human serum and plasma on Roche/Hitachi MODULAR systems and cobas c systems. The affected catalog numbers are 11877771216, 11877780190, 11877798190, and 05976006190. The recall is distributed nationwide in the US, including Puerto Rico.
The recall is being issued because of possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. The source text notes that results of Trinder tests may be falsely decreased when 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.
Healthcare facilities and laboratories using these specific catalog numbers should stop using the affected test kits and contact Roche Diagnostics Operations, Inc. for further instructions on the recall.
The recalled product
- Product
- 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.
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 6,255
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Catalog Numbers:11877771216
- 11877780190
- 11877798190
- 05976006190.
Distribution
Part of a larger recall action
This product is one of 12 recalled by Roche Diagnostics Operations, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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