EliA GBM Wells — Class II medical device recall Z-0783-2024
Ongoing recall by Phadia Ab, reported 2024-01-31, distributed nationwide. Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when
| Recall number | Z-0783-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Phadia Ab, Uppsala, N/A, Sweden |
| Recall initiated | 2023-05-24 |
| Classified | 2024-01-24 |
| Reported by FDA | 2024-01-31 |
| Distributed | Nationwide (US) |
| Quantity | 124,928 kits |
| UPC / GTIN / UDI-DI | 07333066010670 |
Product
EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Reason for recall
Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA wells without antigen.
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-0783-2024. 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.