Beckman Coulter Lipase Assay Recalled Due to NAC Interference
Beckman Coulter is recalling Lipase Assay kits because N-acetyl cysteine 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 errors (falsely low results) due to drug interference, which fits the criteria for moderate severity without reported injuries.
Plain-English summary
Beckman Coulter Inc. is recalling the Lipase Assay, Catalog No. OSR6X30. The recall affects 75,959 units total, with 31,233 units distributed in the United States and Puerto Rico. The product was distributed worldwide to numerous countries.
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 lipase.
The recalled product
- Product
- Beckman Coulter, Lipase Assay, Catalog No. OSR6X30
- 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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