Tosoh ST-AIA Prolactin 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 Prolactin assay kits (Part Number 025255) are recalled because they can cause false high or low test results when used with certain hormone tests. This could lead to incorrect medical decisions if the assay is used improperly.

Why it’s dangerous

The assay kit can interfere with certain hormone tests, causing false high or low readings. This might lead to incorrect medical conclusions if the test is used without proper validation.

Who’s affected

Users of reproductive hormone tests who have the ST-AIA Prolactin assay kit (Part 025255) are affected. People using these kits for medical testing may be at risk of inaccurate results.

How to tell if you have this one

Check for the ST-AIA Prolactin assay kit with Part Number 025255. All lot codes are affected, so any kit with this part number is included in the recall.

Brand
Tosoh Bioscience
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Details
Verify the Part Number 025255 on the kit to confirm if it's affected.

✎ GovInfoNow

Questions people ask

What is the specific product being recalled?

The ST-AIA Prolactin assay kit with Part Number 025255 (all lot codes).

How does this recall affect medical testing?

Using this kit with certain hormone tests may cause false high or low results, potentially leading to incorrect medical decisions.

Do I need to stop using this product?

The recall does not require stopping use; it only advises checking kit details for potential interference.

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-2087-2018 — Tosoh Bioscience Tosoh Bioscience

Hello,

I own a Tosoh Bioscience that is covered by recall Z-2087-2018 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-2087-2018 (March 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2087-2018 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 Prolactin; Part Number: 025255 Assay, Reproductive Hormone

Lower-risk recall