Tosoh Bioscience Inc recalls ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh…

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…

Date

2026-07-22

Country

United States

Brand

Tosoh Bioscience Inc

Product

ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh…

Classification

Class II

Units

Global Distribution. US Nationwide.

Category

Drugs & medical

Source

FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

1. Check the product name, strength and lot number against the official notice.
2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

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