Device recall
Z-1369-2024: Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the…
FDA device recall · Class II · Randox Laboratories Ltd.
Key facts
| Recall number (Z-number) | Z-1369-2024 |
|---|---|
| Recall event | 94088 |
| Product | Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699 |
| Product code | NDY |
| Recalling firm | Randox Laboratories Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K083906 |
| FEI number | 1000361607 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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