Beckman Coulter Enzymatic Creatinine Reagent Recalled for Potential Diagnostic Interference
Beckman Coulter is recalling Enzymatic Creatinine Reagents because high levels of acetaminophen metabolites may interfere with test results, potentially delaying diagnosis.
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 involves a risk of harm (delayed diagnosis and treatment) due to diagnostic interference, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Beckman Coulter Inc is recalling 2,581 units of Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298. 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 instructions on return or replacement. The agency has classified this as a Class II recall.
The recalled product
- Product
- Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx Only, UDI: 15099590625733
- Manufacturer
- Beckman Coulter Inc
- Affected units
- 2,581
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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