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Phadia Ab recalls EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Recalled January 31, 2024 · FDA recall Z-0783-2024 · Phadia Ab
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. · FDA Class II
Units
124,928 kits
Sold at
US Nationwide.
Description
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.
Product
EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Manufacturer(s)
Phadia Ab
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →