Device recall
Z-1907-2019: EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended…
FDA device recall · Class II · Phadia Ab
Key facts
| Recall number (Z-number) | Z-1907-2019 |
|---|---|
| Recall event | 82979 |
| Product | EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin and EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and… |
| Product code | DHR |
| Recalling firm | Phadia Ab |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 2, 2020 |
| 510(k) numbers | K102673, K182747 |
| FEI number | 3002807876 |
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