Z-0783-2024 Class II Ongoing
FDA device recall Z-0783-2024 was initiated by Phadia Ab on May 24, 2023 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 124,928 kits.
Recall Details
- Product Type
- Devices
- Report Date
- January 31, 2024
- Initiation Date
- May 24, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 124,928 kits
Product Description
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.
Distribution Pattern
US Nationwide.
Code Information
UDI-DI: 07333066010670; All Lots.