FDA Enforcement
Class II
Ongoing
EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Recall: Z-0783-2024
·
Reported January 31, 2024
Enforcement
- Recall Number
- Z-0783-2024
- Event ID
- 93403
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Phadia Ab
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 31, 2024
- Initiation Date
- May 24, 2023
- Classification Date
- January 24, 2024
- Address
- Rapsgatan Plant, Rapsgatan 7, Uppsala, N/A, N/A, Sweden
Description
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.
Code Info
UDI-DI: 07333066010670; All Lots.
Distribution
US Nationwide.
Quantity
124,928 kits