Beckman Coulter Cholesterol Reagent Recalled for Potential Drug Interference
Beckman Coulter is recalling Cholesterol Reagent (Catalog No. 467825) because specific drugs may cause false low 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 interference leading to false low results, which is a diagnostic accuracy issue rather than a direct physical injury or high-risk pathogen exposure, fitting the Moderate criteria for low-risk contamination or labeling/accuracy errors.
Plain-English summary
Beckman Coulter Inc. is recalling Cholesterol Reagent (CHOL 2 x 300), Catalog No. 467825, which is intended for the quantitative determination of cholesterol concentration in human serum or plasma. The recall involves 128,718 units total, with 47,858 units distributed in the United States. The product was distributed worldwide to numerous countries, including the United States, Canada, and various nations in Europe, Asia, and the Middle East.
The recall was initiated because Beckman Coulter identified that the drugs Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine may act as potential sources of interference. The presence of these substances may result in false low cholesterol results. The recall applies to all lots of the product.
Healthcare providers and laboratories should stop using the affected reagent. Users should contact Beckman Coulter for further instructions regarding the return or replacement of the product.
The recalled product
- Product
- Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative determination of cholesterol concentration in human serum or plasma.
- Manufacturer
- Beckman Coulter Inc.
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 (1)
- all lots
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 7 recalled by Beckman Coulter 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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