Device recall
Z-2040-2023: EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number…
FDA device recall · Class II · Phadia US Inc
Key facts
| Recall number (Z-number) | Z-2040-2023 |
|---|---|
| Recall event | 92365 |
| Product | EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease Material Number… |
| Product code | MST |
| Recalling firm | Phadia US Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K093459 |
| FEI number | 3004973408 |
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