Tosoh ST AIA-PACK Testosterone Recall: In Vitro Diagnostic Use Only

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Recalling firmTosoh Bioscience Inc3600 Gantz Rd · Grove City, OH 43123-1895

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Tosoh is recalling all lots of ST AIA-P: This product is designed for in vitro diagnostic use only and measures testosterone in human serum. The recall is because it's intended for lab use only, not for home testing.

Why it’s dangerous

The product is designed for use with specific Tosoh AIA System analyzers in laboratory settings. It is not intended for home or non-clinical use, which could lead to incorrect results if used improperly.

Who’s affected

Users of this product for in vitro diagnostic testing. Laboratory staff and healthcare professionals who use the ST AIA-PACK Testosterone (TES) for clinical testing are most at risk.

How to tell if you have this one

Check for the ST AIA-PACK Testosterone (TES) product name. All lots are affected. This product is used for in vitro diagnostic testing in laboratories.

Brand
Tosoh
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the product name and lot number to confirm it is the recalled ST AIA-PACK Testosterone (TES).

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The product is designed for in vitro diagnostic use only and is safe when used with specific laboratory analyzers as intended.

Why is this being recalled?

The recall is because the product is intended for laboratory use only, not for home or non-clinical settings.

What should I do if I have this product?

Check the product details to confirm it is the recalled ST AIA-PACK Testosterone (TES) and ensure it is used only with specific laboratory analyzers.

Take action

Contact Tosoh

We’ve drafted a message you can send Tosoh to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0674-2019 — Tosoh Tosoh

Hello,

I own a Tosoh that is covered by recall Z-0674-2019 from Tosoh.

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-0674-2019 (November 30, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0674-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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 Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of

Lower-risk recall