Device recall
Z-1097-2022: CK MB Calibrator, Catalogue Number CK2393
FDA device recall · Class III · Randox Laboratories Ltd.
Key facts
| Recall number (Z-number) | Z-1097-2022 |
|---|---|
| Recall event | 90046 |
| Product | CK MB Calibrator, Catalogue Number CK2393 |
| Product code | CGS |
| Recalling firm | Randox Laboratories Ltd. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 26, 2023 |
| FEI number | 1000361607 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database