Drug recall
CK MB Calibrator, Catalogue Number CK2393
FDA recall event 90046 · Class III · Randox Laboratories Ltd.
Key facts
| Event ID | 90046 |
|---|---|
| Recall numbers | Z-1097-2022 |
| Recalling firm | Randox Laboratories Ltd. |
| Product type | Devices |
| Products | CK MB Calibrator, Catalogue Number CK2393 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value will cause a positive shift of approximately 6% with both Quality Controls and Patient Samples. |
| Initiation date | Mar 25, 2022 |
| Report date | May 25, 2022 |
| Termination date | Dec 26, 2023 |
| 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: