Roche HDL-Cholesterol Reagent Recalled for Potential Drug Interference
Roche Diagnostics is recalling HDL-Cholesterol plus gen.3. reagents due to potential false results when used with certain drugs.
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, but the hazard involves potential false test results rather than direct physical injury or reported illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 6,255 units of HDL-Cholesterol plus gen.3. and Small Supersized reagents. These products are intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of HDL-cholesterol concentration in serum and plasma. The recall covers catalog numbers 05401488190, 0439980319, 05168805190, 04399803190, and 04878205160.
The recall is due to a 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.
The affected products were distributed nationwide in the United States, including Puerto Rico. Healthcare facilities and laboratories should contact Roche Diagnostics for instructions on how to return the affected units.
The recalled product
- Product
- HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of HDL-cholesterol concentration 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 (5)
- Catalog Numbers: 05401488190
- 0439980319
- 05168805190
- 04399803190
- 04878205160.
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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