Phadia US Inc FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin Class IIMay 1, 2023Higher reported results when running EliA GliadinDP IgG Well	Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to runn	Class IIDevices	May 1, 2023
EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP IgG is intended for tClass IIMay 1, 2023Higher reported results when running EliA GliadinDP IgG Well	Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to runn	Class IIDevices	May 1, 2023