Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement Recalled by Phadia US Inc Due to Higher reported results when running EliA GliadinDP IgG...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Phadia US Inc directly.
Affected Products
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
Quantity: 9 units
Why Was This 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
Where Was This Sold?
This product was distributed to 3 states: CA, MI, NJ
About Phadia US Inc
Phadia US Inc has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report