Z-0210-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 30, 2019
- Initiation Date
- August 24, 2018
- Termination Date
- August 2, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20,926 units
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.
Distribution Pattern
Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada.
Code Information
All lots