Tosoh Bioscience recalls ST-AIA PACK TT3 thyroid assay kits with part number 025282 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 Bioscience is recalling thyroid assay kits that could cause false test results when used with certain medications. This means your thyroid test results might be inaccurate if you use these kits with Asfotase Alfa (Strensiq).
The assay kits can interfere with Asfotase Alfa (Strensiq) medication tests, causing false high or low results depending on the specific test. This happens because the medication affects the assay's chemical process.
People using the ST-AIA PACK TT3 thyroid assay kits with part number 025282 are affected. Those who have Asfotase Alfa (Strensiq) medication are most at risk of inaccurate test results.
Check for the ST-AIA PACK TT3 label with part number 025282. All lot codes of this product are affected.
Look for the ST-AIA PACK TT3 label with part number 025282 on the kit.
No, the recall does not require stopping use. The kits may still be used but could cause inaccurate test results.
The recall does not specify a return or disposal action. Check with your healthcare provider for guidance.
The affected product is the ST-AIA PACK TT3 thyroid assay kit with part number 025282, all lot codes.
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-2078-2018 — Tosoh Biosc: Inc Tosoh Biosc: Inc Hello, I own a Tosoh Biosc: Inc that is covered by recall Z-2078-2018 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.
