Phadia 2500EE instrument -Intended for the in vitro semi-quantitative… — Class II medical device recall Z-2041-2023
Ongoing recall by Phadia US Inc, reported 2023-07-05, distributed in CA, MI, NJ. Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to runn
| Recall number | Z-2041-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Phadia US Inc, Portage, MI, United States |
| Recall initiated | 2023-05-01 |
| Classified | 2023-06-29 |
| Reported by FDA | 2023-07-05 |
| Distributed | CA, MI, NJ |
| Quantity | 9 units |
| UPC / GTIN / UDI-DI | 07333066020938 |
Product
Phadia 2500EE instrument -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 12410002
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2041-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.