Device recall
Z-1547-2020: Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product…
FDA device recall · Class II · Randox Laboratories Ltd.
Key facts
| Recall number (Z-number) | Z-1547-2020 |
|---|---|
| Recall event | 85030 |
| Product | Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy. |
| Product code | JJY |
| Recalling firm | Randox Laboratories Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K140971 |
| 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