Phadia recalls software version 2.1.4 for Phadia 250 instruments used with EliA assays. Using the OK to All function may cause incorrect sample rejections. Affected users should stop using the software until updated.
We want to inform all Phadia 250 system operators performing EliA Assays not to use the function OK to All in any version of Phadia Prime, up to and including 2.1.4, when rejecting and retesting samples with any EliA assay (the OK function may be used for rejecting single tests and dilution of samples in accordance with product DfU).
Phadia is recalling software version 2.1.4 for their 250 instruments when used with certain EliA assays. The software may cause incorrect sample rejections if the 'OK to All' function is used during retesting. This could lead to inaccurate test results.
The 'OK to All' function in Phadia Prime software versions up to 2.1.4 may cause the system to incorrectly reject samples when retesting EliA assays. This could lead to inaccurate test results, potentially affecting diagnosis and treatment decisions.
Users of Phadia 250 instruments with EliA assays who perform tests using the 'OK to All' function. Those testing for specific conditions like celiac disease or autoimmune disorders are most at risk.
Check if your Phadia 250 instrument has software version 12-4101-00 up to 2.1.4. The affected software works with specific EliA assays listed in the recall notice.
Do not use the 'OK to All' function when retesting samples with any EliA assay until the software is updated.
Software versions up to and including 2.1.4 (article number 12-4101-00).
Using the 'OK to All' function during retesting of EliA assays may cause incorrect sample rejections, leading to inaccurate test results.
Check if your Phadia 250 instrument has software version 12-4101-00 up to 2.1.4, which works with specific EliA assays listed in the recall.
We’ve drafted a message you can send Phadia to request your refund or repair — edit it as you like.
Subject: Recall Z-1276-2018 — Phadia Phadia Hello, I own a Phadia that is covered by recall Z-1276-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
