Tosoh ST-AIA PACK HCG 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 recalls all units of their ST-AIA PACK HCG assay (Part Number 025261) because it can cause false test results when used with certain assays. This means test results might be inaccurate, which could lead to incorrect health decisions.

Why it’s dangerous

The ST-AIA PACK HCG assay can interfere with certain tests, causing results to be too high or too low. This happens because the assay contains a substance that affects the testing process.

Who’s affected

Users of reproductive hormone assays who test with this ST-AIA PACK HCG assay may see inaccurate results. Those using the assay for pregnancy or hormone testing are most at risk.

How to tell if you have this one

Check for the ST-AIA PACK HCG assay with Part Number 025261. All lot codes are affected. This product is sold by Tosoh Bioscience Inc.

Brand
Tosoh Biosc: Inc
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify if your assay has Part Number 025261 and is labeled as ST-AIA PACK HCG.

✎ GovInfoNow

Questions people ask

Is there a fix for this issue?

The official recall notice does not specify any remedy.

Do I need to stop using this product?

No specific action is required beyond checking if your product is affected.

What happens if I use this product?

Using this product with certain assays may cause false test results, which could lead to inaccurate health decisions.

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-2083-2018 — Tosoh Biosc: Inc Tosoh Biosc: Inc

Hello,

I own a Tosoh Biosc: Inc that is covered by recall Z-2083-2018 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-2083-2018 (March 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2083-2018 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 ¿HCG; Part Number: 025261 Assay, Reproductive Hormone

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