Device recall
Z-1016-2019: Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the…
FDA device recall · Class II · Randox Laboratories Ltd.
Key facts
| Recall number (Z-number) | Z-1016-2019 |
|---|---|
| Recall event | 81783 |
| Product | Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems. |
| Product code | JIT |
| Recalling firm | Randox Laboratories Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K023763 |
| 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