FDA recall, , Moderate risk
Tosoh ST AIA-Pack Testosterone Test
The test cup lot F level 1 low-quality control results were lower than expected, which could cause falsely elevated or falsely low total testosterone results.
Summary by Recall Canary from the FDA notice
What happened
Tosoh Bioscience Inc, of Grove City, Ohio, recalled the ST AIA-Pack Testosterone, an in vitro diagnostic used for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers, Model Number 0025204.
The recall was initiated on June 12, 2026, because the Test cup lot F level 1 low-quality control results were lower than expected on the Automated Immunoassay Analyzer (AIA), which could cause falsely elevated or falsely low total testosterone results.
Such erroneous results may lead to additional testing or diagnostic interventions and, in limited cases, may delay diagnosis or cause unnecessary or incorrect clinical treatment.
The device was distributed nationwide in the United States. The recall was added to the FDA's Enforcement Report on July 16, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
ST AIA-Pack Testosterone, In Vitro Diagnostic Use Only for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers, Model Number 0025204
- UDI-DI
- 14560189210032
- Lot code
- FX12404
- FY12407
- FY12406
- FZ12408
Recall details
- Company began the recall
- Sold in
Global Distribution. US Nationwide.
- Company
- Tosoh Bioscience IncGrove City, Ohio
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99210
- Recall number
- Z-2746-2026
- Quantity recalled
- 310 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
