Device recall
Z-1631-2018: Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361…
FDA device recall · Class II · Randox Laboratories Ltd.
Key facts
| Recall number (Z-number) | Z-1631-2018 |
|---|---|
| Recall event | 79767 |
| Product | Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage: For Professional Use for the quantitative in vitro determination of Lipase in human serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the… |
| Product code | CDT |
| Recalling firm | Randox Laboratories Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 11, 2019 |
| FEI number | 1000361607 |
At a glance
- None 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