FDA Device recall Z-0783-2024
EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000
- FDA Device
- Class II
- ongoing
- Published 2024-01-31
On 2024-01-31 the FDA classified a Class II recall of EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000 by Phadia Ab, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0783-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-24 |
| Published | 2024-01-31 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Phadia Ab |
| Distribution | US |
Product
EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Reason
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.
Identifiers
| code_info | UDI-DI: 07333066010670; All Lots. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0783-2024%22
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