Recall Z-0210-2020— Beckman Coulter Inc.
Class II · Terminated
Class II FDA medical device recall by Beckman Coulter Inc., initiated 2018-08-24, terminated 2024-08-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Beckman Coulter Lipase, REF OSR6130 and OSR6230.. Reason: NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients..
- Recalling firm
- Beckman Coulter Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-08-24
- Terminated
- 2024-08-02
- Firm location
- Brea, CA, United States
Product description
Beckman Coulter Lipase, REF OSR6130 and OSR6230.
Reason for recall
NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.
Data sourced from openFDA. This site is unofficial and independent of the FDA.