Tosoh ST-AIA PACK Prog II 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 PACK Prog II assay (Part 025239) may produce false test results for reproductive hormones. This could lead to incorrect medical conclusions if used in hormone testing.

Why it’s dangerous

The assay may produce false high or low results when used with Asfotase Alfa (Strensiq) medication. This could lead to incorrect medical decisions if the test is part of a treatment regimen.

Who’s affected

Users of reproductive hormone tests who have the ST-AIA PACK Prog II assay (Part 025239) are affected. Those with medical conditions requiring hormone testing are most at risk.

How to tell if you have this one

Check for the ST-AIA PACK Prog II assay with Part Number 025239. All lot codes are affected. This product is used in 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 you have the ST-AIA PACK Prog II assay with Part Number 025239.

✎ GovInfoNow

Questions people ask

Why is this recall happening?

The assay may produce false high or low results when used with Asfotase Alfa (Strensiq) medication.

What should I do if I have this product?

Check if you have the ST-AIA PACK Prog II assay with Part Number 025239. No specific action is required beyond checking.

Is there a risk of serious injury?

The recall involves potential false test results, not direct injury risks. This is a low-risk situation.

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-2091-2018 — Tosoh Bioscience Tosoh Bioscience

Hello,

I own a Tosoh Bioscience that is covered by recall Z-2091-2018 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-2091-2018 (March 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2091-2018 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 Prog II; Part Number: 025239 Assay, Reproductive Hormone

Lower-risk recall