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

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Contact the company & request your remedy

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

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Tosoh Bioscience is recalling thyroid assay kits that could give false high or low results in certain tests. This means your thyroid test results might be inaccurate if you use these kits.

Why it’s dangerous

The assay kits can interfere with certain thyroid tests, causing results to be too high or too low. This might lead to incorrect medical decisions if the tests are used for diagnosis or monitoring.

Who’s affected

People using thyroid assay kits from Tosoh Bioscience that have the part number 025270 are affected. Those who rely on these kits for medical testing are most at risk.

How to tell if you have this one

Check for the part number 025270 on the ST-AIA PACK TU thyroid assay kit. All lot codes of this product are affected.

Brand
Tosoh Biosc: Inc
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Details
Look for the part number 025270 on the ST-AIA PACK TU thyroid assay kit.

✎ GovInfoNow

Questions people ask

Why is this recall happening?

The assay kits can interfere with certain thyroid tests, causing results to be too high or too low.

How do I know if I have the recalled product?

Check for the part number 025270 on the ST-AIA PACK TU thyroid assay kit. All lot codes of this product are affected.

What should I do if I have the recalled product?

The recall record does not specify a remedy, so contact Tosoh Bioscience for guidance.

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-2082-2018 — Tosoh Biosc: Inc Tosoh Biosc: Inc

Hello,

I own a Tosoh Biosc: Inc that is covered by recall Z-2082-2018 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-2082-2018 (March 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2082-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 27, 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 TU; Part Number: 025270 Assay, Thyroid

Lower-risk recall