Drug recall
Apo B Reagent, REF: OSR6143
FDA recall event 96746 · Class III · Beckman Coulter Ireland, Inc.
Key facts
| Event ID | 96746 |
|---|---|
| Recall numbers | Z-1815-2025 |
| Recalling firm | Beckman Coulter Ireland, Inc. |
| Product type | Devices |
| Products | Apo B Reagent, REF: OSR6143 |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which… |
| Initiation date | Apr 23, 2025 |
| Report date | Jun 4, 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: