Device recall
Z-0969-2018: Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
FDA device recall · Class III · Randox Laboratories
Key facts
| Recall number (Z-number) | Z-0969-2018 |
|---|---|
| Recall event | 79076 |
| Product | Immunoassay Premium Controls (3x4x5mL and 12x5mL packages) |
| Product code | JJY |
| Recalling firm | Randox Laboratories |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 29, 2019 |
| 510(k) numbers | K140522 |
| FEI number | 3003059701 |
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