medical MODERATE Updated 2026-07-22

Tosoh Bioscience Inc recalls ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for t

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Recalled Product

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

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Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 14560189210032; Lot Numbers: FX12404, FY12407, FY12406, FZ12408

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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