Tosoh ST-AIA Estradiol 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 estradiol assay kits (part number 025274) because they can cause false high or low test results when used with certain hormone tests. This could lead to incorrect reproductive health assessments.

Why it’s dangerous

The assay kits can produce false high or low readings when used with certain hormone tests. This might lead to incorrect reproductive health assessments if the test results are relied upon.

Who’s affected

Users of estradiol assay kits (part #025:025274) for reproductive hormone testing. People using these kits for medical testing may get inaccurate results.

How to tell if you have this one

Check for the product name 'ST-AIA PACK Estradiol' and part number 025274. All lot codes are affected.

Brand
Tosoh Bioscience
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the product name and part number to confirm if it's affected.

✎ GovInfoNow

Questions people ask

Why is this recall happening?

The assay kits can cause false high or low test results when used with certain hormone tests.

What should I do if I have this product?

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

Is there a risk of serious injury?

The recall does not mention any risk of serious injury, so this is a low-risk issue.

Take action

Contact Tosoh Bioscience

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

✉️ Open in email

Subject: Recall Z-2088-2018 — Tosoh Bioscience Tosoh Bioscience

Hello,

I own a Tosoh Bioscience that is covered by recall Z-2088-2018 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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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-2088-2018 (March 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2088-2018 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 Estradiol; Part Number: 025274 Assay, Reproductive Hormone

Lower-risk recall