ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for… recallZ-2746-2026 · Tosoh Bioscience Inc · initiated Jun 12, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Tosoh Bioscience Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Component design/selection
What the company is doing
Tosoh Bioscience Inc. sent an URGENT: MEDICAL DEVICE RECALL letter dated 6/9/26 to customers. Customers are to SEGREGRATE and quarantine all affected lots in inventory. Affected product lot should not be used. CONTACT Tosoh Customer Service department at 1-866-527-3587 to arrange return of the affected product. For questions, contact Tosoh Technical Support [email protected] or 1-800-248-6764. For replenishment of returned Testosterone test cups, contact Customer Service department at 1-866-527-3587. Replenishments will be with ST AIA-PACK Testosterone Assay Test Cups from new lots. If you have obtained unexpected test results or received any complaints of illness or adverse events associated with the use of the ST AIA-PACK Testosterone Assay Test Cups and associated Testosterone reagents, contact Tosoh Technical Support at 1-800-248-6764 or [email protected] Monday to Thursday 8:30AM-8:30PM EST Friday 8:30AM-7:30PM EST An URGENT: MEDICAL DEVICE RECALL: SECOND NOTIFICATION: dated 7/17/26 was sent to customers. The letter has additional language regarding the risks to health associated with the use of the affected lots. Instructions to customers are the same as in the first letter.
Recall details
- Recall number
- Z-2746-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 12, 2026
- Posted by the FDA
- Jul 16, 2026
- Recalling firm
- Tosoh Bioscience Inc
- Quantity
- 310 units
- Product code
- CDZ
- FDA submissions
- K023091
- Distribution
- Global Distribution. US Nationwide.
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
Code information (models, lots, serial numbers)
UDI-DI: 14560189210032; Lot Numbers: FX12404, FY12407, FY12406, FZ12408
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ST AIA-PACK Testosterone N/ATosoh Corporation · Radioimmunoassay, Testosterones And Dihydrotestosterone1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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