Phadia US Inc recalls 2500EE instruments that may show higher results for gliadin tests than the 2500 instrument. Affected units have specific serial numbers and were sold for celiac disease testing.
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 US Inc is recalling its 2500EE laboratory instruments because they may produce higher test results for gliadin antibodies than the 2500 model. This could lead to inaccurate celiac disease diagnoses if used improperly.
The 2500EE instrument may report higher levels of gliadin antibodies than the 2500 model when running the same test. This difference could cause false positives in celiac disease diagnosis if not corrected.
Lab users who own or operate the Phadia 2500EE instrument for celiac disease testing are affected. Those testing for gliadin antibodies may be at risk of inaccurate results.
Check your Phadia 2500EE instrument's serial number. The product was sold for celiac disease testing and has a specific material number (12410002) and UDI (07333066020938).
Identify your Phadia 2500EE instrument's serial number to confirm if it is affected.
The 2500EE instrument may produce higher results for gliadin tests compared to the 2500 model, potentially leading to inaccurate celiac disease diagnoses.
Check your Phadia 2500EE instrument's serial number. Affected units have specific serial numbers and were sold with material number 12410002 and UDI 07333066020938.
The recall does not require immediate action. Check your serial number to confirm if affected; no remedy is provided in the official notice.
We’ve drafted a message you can send Phadia to request your refund or repair — edit it as you like.
Subject: Recall Z-2041-2023 — Phadia Phadia Hello, I own a Phadia that is covered by recall Z-2041-2023 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.
