Beckman Coulter Uric Acid Assay Recalled Due to NAC Interference
Beckman Coulter is recalling Uric Acid Assay kits because N-acetyl cysteine administration can cause falsely low test 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, but the hazard is a specific analytical interference (falsely low results) rather than a direct physical injury or high-risk pathogen, fitting the Moderate category for low-risk contamination or labeling/functional errors without reported harm.
Plain-English summary
Beckman Coulter Inc. is recalling the Uric Acid Assay, Catalog No. OSR6X98. The recall affects 32,159 units total, with 10,462 units distributed in the United States. The product was distributed nationwide in the US and Puerto Rico, as well as in 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 assay. This interference may lead to falsely low results for uric acid levels.
Healthcare facilities and laboratories should stop using the affected Uric Acid Assay kits. Users should contact Beckman Coulter Inc. for further instructions regarding the recall and potential replacement or refund.
The recalled product
- Product
- Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98
- 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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