Device recall
Z-2490-2019: This is an in vitro diagnostic product intended for use as a calibration serum…
FDA device recall · Class III · Randox Laboratories Ltd.
Key facts
| Recall number (Z-number) | Z-2490-2019 |
|---|---|
| Recall event | 83373 |
| Product | This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually… |
| Product code | JIX |
| Recalling firm | Randox Laboratories Ltd. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 17, 2020 |
| 510(k) numbers | K053153 |
| 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