Recall Z-0210-2020 ยท CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Beckman Coulter Inc.
Beckman Coulter Lipase, REF OSR6130 and OSR6230.
| Date | Aug 24, 2018 |
| Status | Terminated |
| Reason | NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 20,926 units |
| Distribution | Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.