Beckman Coulter Uric Acid — Class II medical device recall Z-0211-2020
Terminated recall by Beckman Coulter Inc., reported 2019-10-30, distributed nationwide. NAPQI, a metabolite of Acetominophen, causes negative interference with the recalled product assays at levels
| Recall number | Z-0211-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2018-08-24 |
| Classified | 2019-10-24 |
| Reported by FDA | 2019-10-30 |
| Terminated | 2024-08-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 19,834 uits |
| Model numbers | OSR6098, OSR6198, OSR6698 |
Product
Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0211-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.