Class II
Medical Device Recall: EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Phadia Ab · May 24, 2023
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
US Nationwide.
States Affected
NATIONWIDE
Quantity Affected
124,928 kits
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0783-2024
Status: ongoing
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