Home / Recalls / Medical Devices
Phadia US Inc recalls Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin
Recalled July 5, 2023 · FDA recall Z-2041-2023 · Phadia US
Hazard
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 · FDA Class II
Units
9 units
Sold at
US: CA, NJ, MI
Description
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
Product
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
Manufacturer(s)
Phadia US Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →