Phadia Ab recalls EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic

Recall date

May 24, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0783-2024

FDA classification

Class II

Brand / firm

Phadia Ab

Sold / distributed

US Nationwide.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic