ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum o
Summary
The FDA issued a Class II for ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative meas by Tosoh Bioscience Inc. 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) whic.
Details
Source
Device Recall
External ID
Z-2746-2026
Action Date
2026-07-22
Status
Ongoing
Category
device
Product 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
Lot/Code Info: UDI-DI: 14560189210032; Lot Numbers: FX12404, FY12407, FY12406, FZ12408
Quantity Affected: 310 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-12
Company
Grove City, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 102 device recalls issued in the same week, part of 365 device-related FDA actions this month.
Tosoh Bioscience Inc has 4 FDA actions in our database, including 1 recall and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Tosoh Bioscience Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Tosoh Bioscience Inc have FDA actions?
Tosoh Bioscience Inc has 4 FDA actions in our database, including 1 recall and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2746-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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