Quick Facts at a Glance
- Recall Date
- June 12, 2026
- Hazard Level
- HIGH
- Brand
- Tosoh Bioscience
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Tosoh Bioscience
- Model numbers
- UDI-DI: 14560189210032, Lot Numbers: FX12404, FY12407, FY12406, FZ12408
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
June 12, 2026
Reported by FDA DEVICE
July 22, 2026
RecallRadar source check
July 28, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Tosoh Bioscience Inc or your healthcare provider for instructions. Notification method: Letter
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Full Description
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. Reason: 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.. Classification: Class II. Quantity: 310 units. Distribution: Global Distribution. US Nationwide.
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Safety Guide
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