Phadia US Inc recalls Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin…

Recall date

May 1, 2023

Source

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

Recall number

Z-2041-2023

FDA classification

Class II

Brand / firm

Phadia US Inc

Sold / distributed

US: CA, NJ, MI

Why it was recalled

Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument

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

What was recalled

Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease Material Number 12410002