Tosoh Bioscience recalls AIA-PACK TSH 3rd Generation thyroid assays due to potential false test results from Asfotase Alfa. Affected units include all lot codes of part number 020294.
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Tosoh Biosc: AIA-PACK TSH 3rd Generation thyroid assays (part number 020294) are recalled because they can give false high or low test results when used with Asfotase Alfa medication. This could lead to incorrect health decisions if the tests are relied on.
The assay can produce inaccurate results when used with Asfotase Alfa (Strensiq). This means test results might show higher or lower thyroid hormone levels than actual, potentially leading to wrong health decisions.
People using these thyroid tests with Asfotase Alfa medication may be affected. Those who have recently had thyroid tests with this specific assay are most at risk.
Check for the product name 'AIA-PACK TSH 3rd Generation' and part number 020294 on the label. All lot codes of this assay are affected.
Look for the product name 'AIA-PACK TSH 3rd Generation' and part number 020294 on the label.
The recall is for potential false test results, not immediate danger. It's a low-risk issue that could affect accuracy when used with Asfotase Alfa.
No action is required beyond checking the label. The recall doesn't ask to stop using the assay, only to verify if it's affected.
Check the label for the product name and part number. If it matches, contact Tosoh Bioscience for guidance.
We’ve drafted a message you can send Tosoh Bioscience to request your refund or repair — edit it as you like.
Subject: Recall Z-2077-2018 — Tosoh Bioscience Tosoh Bioscience Hello, I own a Tosoh Bioscience that is covered by recall Z-2077-2018 from Tosoh Bioscience. 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.
