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Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodi...

FDA Recall #Z-2041-2023 — Class II — May 1, 2023

Recall #Z-2041-2023 Date: May 1, 2023 Classification: Class II Status: Ongoing

Product Description

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

Reason for Recall

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

Recalling Firm

Phadia US Inc — Portage, MI

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

9 units

Distribution

US: CA, NJ, MI

Code Information

UDI: 07333066020938 All Serial Numbers

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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