Device product
EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Z-0783-2024
Product summary
- Firm
- Phadia Ab
- Event
- Event 93403
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 124,928 kits
- Official record key
device-enforcement:Z-0783-2024
Official wording
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.
Code information: UDI-DI: 07333066010670; All Lots.
Distribution pattern: US Nationwide.
Derived failure modes
-
Unknown
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.