Device recall
Z-1107-2021: EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative…
FDA device recall · Class II · Phadia US Inc
Key facts
| Recall number (Z-number) | Z-1107-2021 |
|---|---|
| Recall event | 87161 |
| Product | EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE). Material Number: 14-5500-01 |
| Product code | LSW |
| Recalling firm | Phadia US Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 4, 2022 |
| 510(k) numbers | K072393 |
| FEI number | 3002807876 |
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