Beckman Coulter Lipase Recalled Due to Acetaminophen Interference
Beckman Coulter is recalling Lipase assays because acetaminophen metabolites cause negative interference in overdose patients.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the hazard is negative interference in assays for overdose patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Beckman Coulter Inc. is recalling Beckman Coulter Lipase, REF OSR6130 and OSR6230. The recall involves 20,926 units distributed nationwide, including to government and military entities, as well as to Canada.
The recall is due to negative interference with the product assays caused by NAPQI, a metabolite of acetaminophen. This interference occurs at levels present in the serum or plasma of overdose patients.
Healthcare providers and laboratories should stop using the affected units and contact Beckman Coulter for instructions on return or replacement.
The recalled product
- Product
- Beckman Coulter Lipase, REF OSR6130 and OSR6230.
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 20,926
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 nationwide across the United States.
Part of a larger recall action
This product is one of 2 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.
See all 2 products in this recall →Related recalls
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