Tosoh ST-AIA PACK FT4 Thyroid Assay Recall: False Test Results Risk

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Recalling firmTosoh Bioscience Inc3600 Gantz Rd, N/A · Grove City, OH 43123-1895

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Tosoh Bioscience is recalling thyroid assay kits that could give false high or low test results. This affects lab tests for thyroid function and may lead to incorrect health decisions.

Why it’s dangerous

The assay kit contains Asfotase Alfa (Strensiq) which can interfere with certain thyroid tests. This may cause test results to be too high or too low, leading to incorrect health assessments.

Who’s affected

Lab technicians and healthcare providers using the ST-AIA PACK FT4 thyroid assay kits with part number 025268. Those who rely on these kits for thyroid testing are most at risk.

How to tell if you have this one

Check for the ST-AIA PACK FT4 thyroid assay kit with part number 025268. All lot codes are affected. This product is used in laboratory settings for thyroid testing.

Brand
Tosoh Biosc: Inc
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Details
Verify the part number 025268 on the ST-AIA PACK FT4 thyroid assay kit.

✎ GovInfoNow

Questions people ask

Why is this recall happening?

The ST-AIA PACK FT4 thyroid assay kits may cause false high or low test results when used with Asfotase Alfa (Strensiq).

What should I do if I have this kit?

Check the part number on the kit; if it's 025268, contact Tosoh Bioscience for guidance.

Is there a risk of serious injury?

No serious injury risk is described in the recall notice. The hazard is limited to inaccurate test results.

Take action

Contact Tosoh Biosc: Inc

We’ve drafted a message you can send Tosoh Biosc: Inc to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2081-2018 — Tosoh Biosc: Inc Tosoh Biosc: Inc

Hello,

I own a Tosoh Biosc: Inc that is covered by recall Z-2081-2018 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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Where this comes from

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.

Official source: FDA Recall #Z-2081-2018 (March 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2081-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Tosoh Bioscience Inc recalls ST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid

Lower-risk recall