Device recall
Z-1106-2019: Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product…
FDA device recall · Class III · Randox Laboratories Ltd.
Key facts
| Recall number (Z-number) | Z-1106-2019 |
|---|---|
| Recall event | 82184 |
| Product | Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert |
| Product code | JJY |
| Recalling firm | Randox Laboratories Ltd. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 8, 2020 |
| 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