Device recall
Z-1255-2021: Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR…
FDA device recall · Class II · R & D Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1255-2021 |
|---|---|
| Recall event | 87223 |
| Product | Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An enzyme linked immunosorbent assay (ELISA) for the quantitative determination of Soluble Transferrin Receptor (sTfR) concentration in human serum and plasma as an aid in the diagnosis of anemia… |
| Product code | JNM |
| Recalling firm | R & D Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 13, 2023 |
| 510(k) numbers | K970718 |
| 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