Device recall
Z-0660-2019: SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use…
FDA device recall · Class II · Randox Laboratories Ltd.
Key facts
| Recall number (Z-number) | Z-0660-2019 |
|---|---|
| Recall event | 81664 |
| Product | SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution. |
| Product code | JIX |
| Recalling firm | Randox Laboratories Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 23, 2020 |
| 510(k) numbers | K031608 |
| 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