# FDA recall Z-2746-2026

> **Tosoh Bioscience Inc** · Class II · device recall initiated 2026-06-12.

## 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

## Reason for 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.

## Distribution

Global Distribution. US Nationwide.

## Key facts

- **Recall number:** Z-2746-2026
- **Recalling firm:** Tosoh Bioscience Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-06-12
- **Report date:** 2026-07-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Grove City, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2746-2026

## Citation

> MORVS. FDA recall Z-2746-2026. Retrieved 2026-10-21 from https://api.morvs.ai/recall/Z-2746-2026. Source: US FDA. Licensed CC0.

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