Recall Z-0211-2020
Beckman Coulter Inc. · initiated August 24, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698.
Codes / lots: All lots
Reason for recall
NAPQI, a metabolite of Acetominophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.
FDA-determined cause: Nonconforming Material/Component
Action taken
The recalling firm issued letters dated 8/21/2018 via email or postal mail if an email address was not available on 8/24/2018 to their customers. The letter identified the affected product, problem and actions to be taken. For questions call 1-800-223-0139 in the United States and Canada. Outside the United States and Canada contact local Beckman Coulter Representative.
Details
- Recall number
- Z-0211-2020
- Initiated
- August 24, 2018
- Terminated
- August 2, 2024
- Product code
- KNK – Acid, Uric, Uricase (Colorimetric)
- Quantity
- 19,834 uits
- Distribution
- Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada.
- Recalling firm
- Beckman Coulter Inc., Brea, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0210-2020 Class II | Beckman Coulter Lipase, REF OSR6130 and OSR6230.NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assays at… | 08/24/2018Terminated |