Beckman Coulter Cholesterol Assay Recalled Due to NAC Interference
Beckman Coulter is recalling Cholesterol Assay kits because N-acetyl cysteine administration can cause falsely low results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 diagnostic error (falsely low results) due to drug interference, which is a significant but non-acute risk without reported injuries or fatalities.
Plain-English summary
Beckman Coulter Inc. is recalling the Cholesterol Assay, Catalog No. OSR6X16. The recall involves 59,965 units total, with 21,782 units distributed in the United States. The product was distributed nationwide in the US and Puerto Rico, as well as to numerous countries worldwide.
The recall is due to interference from N-acetyl cysteine (NAC). When NAC is administered in therapeutic concentrations for the treatment of acetaminophen overdose, it interferes with the cholesterol assay. This interference may lead to falsely low results, which could impact clinical decision-making.
Healthcare facilities and laboratories should stop using the affected Cholesterol Assay kits. Users should contact Beckman Coulter Inc. for instructions on returning the product or obtaining a replacement.
The recalled product
- Product
- Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16
- 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
Part of a larger recall action
This product is one of 4 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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