Device recall
Z-2021-2023: Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control…
FDA device recall · Class III · Randox Laboratories Ltd.
Key facts
| Recall number (Z-number) | Z-2021-2023 |
|---|---|
| Recall event | 92344 |
| Product | Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640 |
| Product code | JJY |
| Recalling firm | Randox Laboratories Ltd. |
| Recall class | Class III |
| Status | Open, Classified |
| 510(k) numbers | K140522 |
| FEI number | 1000361607 |
At a glance
- 1–9 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