Tosoh ST-AIA PACK HGH Recall: False Assay 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 ST-AIA PACK HGH (Part Number 025266) because it can cause false high or low results in metabolic assays. This means test results might be inaccurate, which could affect medical decisions.

Why it’s dangerous

The ST-AIA PACK HGH product can interfere with certain metabolic assays, causing test results to be either too high or too low. This interference may lead to incorrect medical decisions if the results are used.

Who’s affected

Users of metabolic assays who have the ST-AIA PACK HGH (Part 025266) are affected. Healthcare providers and labs using this product for testing are most at risk.

How to tell if you have this one

Check for the ST-AIA PACK HGH product with Part Number 025266. All lot codes are affected, so any unit with this part number is included in the recall.

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 ST-AIA PACK HGH has Part Number 025266. All lot codes are affected.

✎ GovInfoNow

Questions people ask

Is this product dangerous?

The recall is for potential false assay results, not immediate danger. This is a low-risk issue that could affect test accuracy.

Do I need to stop using this product?

No, the recall does not require stopping use. The issue is about test accuracy, not safety.

How can I confirm if my product is affected?

Check for Part Number 025266 on the ST-AIA PACK HGH product. All lot codes are affected.

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-2095-2018 — Tosoh Biosc: Inc Tosoh Biosc: Inc

Hello,

I own a Tosoh Biosc: Inc that is covered by recall Z-2095-2018 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-2095-2018 (March 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2095-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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 HGH; Part Number: 025266 Assay, Metabolic

Lower-risk recall