Device recall
Z-2753-2020: Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase…
FDA device recall · Class II · RANDOX LABORATORIES, LTD.
Key facts
| Recall number (Z-number) | Z-2753-2020 |
|---|---|
| Recall event | 86039 |
| Product | Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma. |
| Product code | CHI |
| Recalling firm | RANDOX LABORATORIES, LTD. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 19, 2020 |
| 510(k) numbers | K020238 |
| FEI number | 3006697287 |
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