Tosoh ST-AIA DHEA-S 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 Biosc: ST-AIA DHEA-S assay (Part Number 025222) is recalled because it can cause false high or low results in certain hormone tests. This means test results might be inaccurate, which could affect medical decisions.

Why it’s dangerous

The assay can interfere with certain tests, causing results to be too high or too low. This might lead to incorrect medical conclusions if the test is used for reproductive hormone levels.

Who’s affected

People using this assay for reproductive hormone testing. Those with medical conditions requiring precise hormone measurements are most at risk.

How to tell if you have this one

Check for the product name 'ST-AIA DHEA-S' with Part Number 025222. All lot codes are affected. This assay is used for reproductive hormone testing.

Brand
Tosoh Bioscience
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify if your assay has the Part Number 025222 for reproductive hormone testing.

✎ GovInfoNow

Questions people ask

Why is this assay being recalled?

The assay can cause false high or low results in certain hormone tests, which might lead to incorrect medical decisions.

What should I do if I have this assay?

Check if your assay has Part Number 025222 for reproductive hormone testing. If so, contact Tosoh Bioscience for guidance.

Is there a risk of serious injury?

No serious injury risk is mentioned in the recall. The issue is with test accuracy, not physical harm.

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-2085-2018 — Tosoh Bioscience Tosoh Bioscience

Hello,

I own a Tosoh Bioscience that is covered by recall Z-2085-2018 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-2085-2018 (March 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2085-2018 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 DHEA-S; Part Number: 025222 Assay, Reproductive Hormone

Lower-risk recall