Phadia Ab recalls EliA RF IgM Well (REF 14-5600-01) due to potential for low assay results. Affected units may lead to inaccurate rheumatoid arthritis testing.
Potential for reporting low assay results
Phadia Ab is recalling EliA RF IgM Well test kits (REF 14-5600-01) because they might produce low assay results, which could lead to inaccurate rheumatoid arthritis testing. This affects users who rely on these kits for diagnosis.
The test kits might produce lower than expected results, leading to inaccurate rheumatoid arthritis diagnosis. This could cause misdiagnosis if the test results are not properly interpreted.
People using EliA RF IgM Well test kits for rheumatoid arthritis diagnosis may be affected. Those who have the specific lot number 0085 are most at risk.
Check for the product name 'EliA RF IgM Well', reference number 14-5600-01, and lot number 0085. The test is used with Phadia 100, 250, 2500, or 5000 instruments.
Verify the product name, reference number, and lot number to confirm if your kit is affected.
EliA RF IgM Well (reference number 14-5600-01) with lot number 0085.
The product may produce low assay results, which could lead to inaccurate rheumatoid arthritis testing.
Check for the product name 'EliA RF IgM Well', reference number 14-5600-01, and lot number 0085.
We’ve drafted a message you can send Phadia Ab to request your refund or repair — edit it as you like.
Subject: Recall Z-1907-2019 — Phadia Ab Phadia Ab Hello, I own a Phadia Ab that is covered by recall Z-1907-2019 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.
