Tosoh recalls ST-AIA PACK FT3 thyroid assay kits with part number 025286 due to potential false test results. Affected units may cause inaccurate thyroid test results.
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Tosoh is recalling thyroid assay kits that could give false high or low results when used with certain tests. This means your test results might be wrong if you use these kits.
The assay kits can interfere with certain tests, causing results to be too high or too low. This might lead to incorrect thyroid health assessments.
People using thyroid assay kits with part number 025286 are affected. Those who rely on accurate thyroid test results are most at risk.
Check for the part number 025286 on the ST-AIA PACK FT3 thyroid assay kit. All lot codes are affected.
Look for part number 025286 on the ST-AIA PACK FT3 thyroid assay kit.
The assay kits can interfere with certain tests, causing false high or low results.
No, but you should check if you have the affected kit to avoid inaccurate test results.
Check the kit for part number 025286; if you have it, you may need to use a different kit for accurate results.
We’ve drafted a message you can send Tosoh Biosc: Inc to request your refund or repair — edit it as you like.
Subject: Recall Z-2080-2018 — Tosoh Biosc: Inc Tosoh Biosc: Inc Hello, I own a Tosoh Biosc: Inc that is covered by recall Z-2080-2018 from Tosoh Biosc: Inc. 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.