Phadia Ab recalls EliA GBM Wells (Material 14551401) for Phadia 250, 2500, and 5000 devices due to false positive results in certain tests. All lots affected.
Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA wells without antigen.
Phadia Ab is recalling specific EliA GBM Wells used with Phadia 250, 2500, and 5000 devices because they can produce false positive results. This means some tests may show a positive result when there's no actual condition present, which could lead to unnecessary medical actions.
The wells can produce false positive results when testing samples for certain conditions. This happens when the test shows a positive signal without the actual antigen being present, leading to incorrect conclusions about the test results.
Users of Phadia 250, 2500, and 5000 devices with the specific EliA GBM Wells (Material Number 14551401) are affected. Laboratory staff and healthcare providers who use these tests are most at risk of receiving inaccurate results.
Check for the Material Number 14551401 on the EliA GBM Wells. These wells are used with Phadia 250, 2500, and 5000 devices and are part of all lots affected by this recall.
Look for the Material Number 14551401 on the EliA GBM Wells to confirm if they are affected.
Phadia Ab is recalling these wells because they can produce false positive results in certain tests, which may lead to incorrect medical conclusions.
Check the Material Number 14551401 on the wells to see if they are affected. If they are, you should stop using them and contact Phadia Ab for further instructions.
The recall is for potential false positive results, which could lead to unnecessary medical actions. However, no specific health risks are mentioned in the recall notice.
We’ve drafted a message you can send Phadia Ab to request your refund or repair — edit it as you like.
Subject: Recall Z-0783-2024 — Phadia Ab Phadia Ab Hello, I own a Phadia Ab that is covered by recall Z-0783-2024 from Phadia Ab. 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.
