Beckman Coulter Uric Acid Assay Recalled Due to Interference
Beckman Coulter is recalling Uric Acid assays because acetaminophen metabolites cause negative interference in overdose patients.
What this means for you
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 is classified as FDA Class II, and the hazard involves a risk of harm (negative interference in overdose patients) without reported injuries or illnesses, fitting the 'High' severity criteria.
Plain-English summary
Beckman Coulter Inc. is recalling Beckman Coulter Uric Acid assays, reference numbers OSR6098, OSR6198, and OSR6698. The recall involves 19,834 units distributed nationwide, including to government and military facilities, as well as to Canada.
The recall is being issued because NAPQI, a metabolite of acetaminophen, causes negative interference with the assays. This interference occurs at levels present in the serum or plasma of patients who have taken an overdose of acetaminophen.
Healthcare facilities and laboratories should stop using the affected products and contact Beckman Coulter for instructions on how to return or dispose of the recalled units.
The recalled product
- Product
- Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698.
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 19,834
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.
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