Device recall
Z-1390-2022: Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative…
FDA device recall · Class III · R & D Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1390-2022 |
|---|---|
| Recall event | 90445 |
| Product | Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations in human serum and plasma. IFU, Part Number 750095 |
| Product code | GGT |
| Recalling firm | R & D Systems, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 24, 2026 |
| 510(k) numbers | K931756 |
| FEI number | 2182501 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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