Recall Z-0211-2020 ยท KNK Acid, Uric, Uricase (Colorimetric)
Beckman Coulter Inc.
Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698.
| Date | Aug 24, 2018 |
| Status | Terminated |
| Reason | NAPQI, a metabolite of Acetominophen, 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 | 19,834 uits |
| 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
| K062862 | OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 Olympus America, Inc., Apr 6, 2007 |