Beckman Coulter Uric Acid Reagent Recalled for Acetaminophen Interference
Beckman Coulter is recalling Uric Acid Reagents because high levels of acetaminophen metabolites may cause negative interference, potentially delaying diagnosis and treatment.
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 source explicitly states the hazard could result in a delay in diagnosis and treatment, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Beckman Coulter Inc is recalling 16,983 units of Uric Acid Reagent (URIC 2 X 300), REF: 442785, for in vitro diagnostic use. The recall covers all lot numbers and includes products distributed across the United States and numerous international locations.
The recall was initiated because N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference in the assay if present in high quantities in serum due to acetaminophen overdoses. This interference could result in a delay in diagnosis and treatment for patients.
Healthcare facilities and laboratories should stop using the affected reagents and contact Beckman Coulter for further instructions.
The recalled product
- Product
- Uric Acid Reagent (URIC 2 X 300), REF: 442785, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575281
- Manufacturer
- Beckman Coulter Inc
- Affected units
- 16,983
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 Lot Numbers
Distribution
Part of a larger recall action
This product is one of 5 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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