FDA Device recall Z-2040-2023
EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP IgG is intended for the in vitro semi-qua…
- FDA Device
- Class II
- ongoing
- Published 2023-07-05
On 2023-07-05 the FDA classified a Class II recall of EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP IgG is intended for the in vitro semi-qua… by Phadia Us, citing higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2040-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-01 |
| Published | 2023-07-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Phadia Us |
| Distribution | CA, MI, NJ |
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 14553901
Reason
Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument
Identifiers
| code_info | UDI: 07333066010847 All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2040-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.