Roche HDL-Cholesterol gen.3. Recalled for Potential Drug Interference
Roche Diagnostics is recalling HDL-Cholesterol gen.3. reagents due to potential false results caused by drug interference on Cobas Analyzers.
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, and the hazard involves potential inaccurate test results due to drug interference, which fits the criteria for moderate severity without reported injuries.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling HDL-Cholesterol gen.3. reagents, which are used for the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma. The recall involves 6,255 analytical units distributed nationwide in the United States, including Puerto Rico.
The recall is due to a potential for drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when run with urine samples (specifically for Creatinine plus and Uric Acid applications) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine.
Healthcare facilities and laboratories should stop using the affected reagents and contact Roche Diagnostics for further instructions. The affected catalog numbers are 05401470190, 03263991190, 05168589190, and 03263991190.
The recalled product
- Product
- HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma.
- 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: 05401470190
- 03263991190
- 05168589190
- 03263991190.
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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