FDA-Device2024-01-31Class II
EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
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.
Sold states
US Nationwide.
Affected count
124,928 kits
Manufactured in
Rapsgatan Plant, Rapsgatan 7, Uppsala, N/A, Sweden
Products
EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0783-2024Don't want to check this manually?
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