FDAFDA · Food and drugs·Recall number Z-0783-2024
EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Published January 31, 2024 · Recall initiated: May 24, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Phadia Ab
- Distributor
- US Nationwide.
- Lot
- UDI-DI: 07333066010670; All Lots.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Sweden
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