Phadia recalls EliA GliadinDP IgG Well for Phadia 2500EE instruments due to higher reported results compared to Phadia 2500 instrument. Affected users should check their material number.
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
Phadia is recalling EliA GliadinDP IgG Well for the Phadia 2500EE instrument because it can produce higher test results than the Phadia 2500 instrument. This may lead to inaccurate celiac disease testing results.
The EliA GliadinDP IgG Well for Phadia 2500EE instruments can produce higher reported results compared to the Phadia 2500 instrument. This may cause inaccurate celiac disease test results, potentially leading to incorrect diagnoses.
Users of the Phadia 2500EE instrument with the EliA GliadinDP IgG Well (Material Number 12410002) are affected. People using this test for celiac disease diagnosis are most at risk of inaccurate results.
Check for the Material Number 12410002 on the EliA GliadinDP IgG Well. The product was sold with the Phadia 2500EE instrument.
Look for Material Number 12410002 on the EliA GliadinDP IgG Well.
The EliA GliadinDP IgG Well for Phadia 2500EE instruments can produce higher reported results compared to the Phadia 2500 instrument, potentially causing inaccurate celiac disease test results.
Check the Material Number on the EliA GliadinDP IgG Well. If it is 12410002, you may need to contact Phadia for further instructions.
The recall record does not mention a specific fix or remedy for this issue.
We’ve drafted a message you can send Phadia to request your refund or repair — edit it as you like.
Subject: Recall Z-2040-2023 — Phadia Phadia Hello, I own a Phadia that is covered by recall Z-2040-2023 from Phadia. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.