medical Class II Updated 2023-07-05

Phadia US Inc recalls Phadia 2500EE instrument -Intended for the in vitro semi-qua

Recalled 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

Hazard / Issue

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

Issued by

FDA

Affected States: CA, NJ, MI
Lot/Code Info: UDI: 07333066020938 All Serial Numbers
View official government recall

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