Recall Z-1424-2020— Beckman Coulter Inc
Class II · Terminated
Class II FDA medical device recall by Beckman Coulter Inc, initiated 2019-08-15, terminated 2024-02-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Uric Acid Reagent (URIC 2 X 300), REF: 442785, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575281. Reason: It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quantities in serum due to acetaminophen overdoese. This could result in a delay in diagnosis and treatment..
- Recalling firm
- Beckman Coulter Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-08-15
- Terminated
- 2024-02-28
- Firm location
- Carlsbad, CA, United States
Product description
Uric Acid Reagent (URIC 2 X 300), REF: 442785, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575281
Reason for recall
It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quantities in serum due to acetaminophen overdoese. This could result in a delay in diagnosis and treatment.
Data sourced from openFDA. This site is unofficial and independent of the FDA.