Drug recall
BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the…
FDA recall event 97842 · Class II · Beckman Coulter Ireland, Inc.
Key facts
| Event ID | 97842 |
|---|---|
| Recall numbers | Z-0997-2026 |
| Recalling firm | Beckman Coulter Ireland, Inc. |
| Product type | Devices |
| Products | BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample. |
| Initiation date | Oct 14, 2025 |
| Report date | Dec 31, 2025 |
| City | O'Callaghan'S Mills |
| Country | Ireland |
| FEI number | 1000206808 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: