Drug recall
Calibration Serum Level 3 CAL2351
FDA recall event 93612 · Class II · Randox Laboratories Ltd.
Key facts
| Event ID | 93612 |
|---|---|
| Recall numbers | Z-0752-2024 |
| Recalling firm | Randox Laboratories Ltd. |
| Product type | Devices |
| Products | Calibration Serum Level 3 CAL2351 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of… |
| Initiation date | Nov 20, 2023 |
| Report date | Jan 24, 2024 |
| City | Crumlin (North) |
| Country | Ireland |
| FEI number | 2965 |
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: