Device recall
Z-0691-2019: Quantikine IVD ELISA, Human sTfR Immunoassay kit. Product Usage: The…
FDA device recall · Class III · R & D Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0691-2019 |
|---|---|
| Recall event | 81550 |
| Product | Quantikine IVD ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or plasma as an aid in the diagnosis of iron deficiency anemia, especially the differential diagnosis of… |
| Product code | JNM |
| Recalling firm | R & D Systems, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 3, 2020 |
| 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