Lower risk Medical device recall · FDA · Published June 12, 2026

Tosoh ST AIA-Pack Testosterone Recall: False Test Results Risk

Tosoh recalls specific testosterone test kits that may give false high or low results, causing unnecessary treatments or delayed diagnoses. Affected units include certain lot numbers on specific analyzers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2746-2026Medical device Tosoh ›

Lower-risk recall

The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone results. Such erroneous test results may lead to additional testing/diagnostic interventions and in limited cases, may lead to a delay in diagnosis and/or initiation of unnecessary or incorrect clinical treatment measures.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Tosoh is recalling specific testosterone test kits that could produce inaccurate results. This might lead to extra tests or incorrect treatments, potentially delaying proper care. Read more at govinfonow.com/recall/49004-tosoh-st-aia-pack-testosterone-recall-false-test-results-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/49004-tosoh-st-aia-pack-testosterone-recall-false-test-results-risk · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2746-2026

Cite this page

“Tosoh ST AIA-Pack Testosterone Recall: False Test Results Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49004-tosoh-st-aia-pack-testosterone-recall-false-test-results-risk. Based on FDA recall #Z-2746-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2746-2026%22&limit=1).

Tosoh Bioscience Inc recalled ST AIA-Pack Testosterone in vitro diagnostic kits on June 12, 2026, according to the FDA. The recall affects devices that may produce erroneous testosterone results due to low-quality control values.

How to tell if you have it

Brand: Tosoh
Product: ST AIA-Pack Testosterone
Model Number: 0025204
UDI-DI: 14560189210032
Lot Numbers: FX12404, FY12407, FY12406, FZ12408
Units affected: 310

The hazard

The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA), which could cause falsely elevated or falsely low total testosterone results. Such erroneous test results may lead to additional testing/diagnostic interventions and in limited cases, may lead to a delay in diagnosis and/or initiation of unnecessary or incorrect clinical treatment measures.

Context

GovInfoNow's records show Tosoh Bioscience Inc has 19 other recalls on record since 2017-06-11. Other recent recalls of similar products include Siemens Atellica CH Urine Albumin Recall (2026-07-06), Immunotech Estrone RIA Kit Recall (2025-12-15), and Vivoo Test Strips Recall (2025-11-22).

How to tell if you have this one

Check the lot number on the test kit (FX12404, FY12407, FY12406, FZ12408) and the model number (0025204) for the Tosoh AIA System. The product is labeled as 'ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY'.

Brand
Tosoh
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Lot Number
Look for the lot number on the test kit: FX12404, FY12407, FY12406, or FZ12408.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Global Distribution. US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 40 days after the firm started it.

Jun 12, 2026Firm started the recall
Jul 16, 2026FDA classified it Class II
Jul 22, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using these test kits?

The recall does not require stopping use immediately; check the lot number to see if your kit is affected.

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Link to this recall

<a href="https://govinfonow.com/recall/49004-tosoh-st-aia-pack-testosterone-recall-false-test-results-risk">Tosoh ST AIA-Pack Testosterone Recall: False Test Results Risk (GovInfoNow)</a>

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-2746-2026 (June 12, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2746-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.