Tosoh recalls thyroid assay kits with part number 025258 that may cause false high or low test results when used with Asfotase Alfa (Strensiq).
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 inaccurate test results when used with a specific medication. This affects people who rely on these tests for medical monitoring.
The assay kits may produce false high or low results when used with Asfotase Alfa (Strensiq). This could lead to incorrect medical decisions based on the test results.
People using the ST-AIA PACK T4 thyroid assay kits with part number 025258 are affected. Those who have the medication Asfotase Alfa (Strensiq) are most at risk for inaccurate test results.
Check for the product name 'ST-AIA PACK T4' and part number 025258. All lot codes of this assay are included in the recall.
Verify the product name and part number to confirm if it's recalled.
The assay kits may cause false high or low test results when used with Asfotase Alfa (Strensiq).
The recall does not specify a remedy, so check with your healthcare provider for guidance.
The recall record does not mention a deadline for action.
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-2079-2018 — Tosoh Biosc: Inc Tosoh Biosc: Inc Hello, I own a Tosoh Biosc: Inc that is covered by recall Z-2079-2018 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.
