Class 2 Device Recall ST AIAPack Testosterone

• Date Initiated by Firm: June 12, 2026
• Date Posted: July 16, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2746-2026
• Recall Event ID: 99210
• 510(K)Number: K023091
• Product Classification: Radioimmunoassay, testosterones and dihydrotestosterone - Product Code CDZ
• 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
• Code Information: UDI-DI: 14560189210032; Lot Numbers: FX12404, FY12407, FY12406, FZ12408
• FEI Number: 3005529799
• Recalling Firm/ Manufacturer: Tosoh Bioscience Inc; 3600 Gantz Rd; Grove City OH 43123-1895
• For Additional Information Contact: Isabelle Lang-Zwosta; 615-8064671
• Manufacturer 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.
• FDA Determined Cause: Component design/selection
• Action: An URGENT: MEDICAL DEVICE RECALL notification letter dated 6/9/26 was sent to customers. Immediate Actions to be taken by the Customer 1. REVIEW your inventory for the affected lots. 2. COMMUNICATE and review the information in this notification with the Medical Director and/or Lab Director and with others in your laboratory staff as soon as possible. 3. MAINTAIN this notification with your laboratory records and forward this notification to others in your laboratory staff 4. SEGREGRATE and quarantine all affected lots upon review of your inventory. Affected product lot should not be used. 5. COMPLETE and return the attached acknowledgement form to Tosoh Bioscience Inc. within 15 days of receiving this notification whether you have affected lots or not. Instructions for return of your remaining product to Tosoh Bioscience Inc. are stated below. Return of Product and Available Assistance: CONTACT the Tosoh Customer Service department at 1-866-527-3587 to arrange return of the affected product. Since this recall might affect availability of the product on the market, we will only be able to accommodate limited order quantities. Representatives can also answer questions related to replacements. For questions related to this notification and/or acknowledgement form that are not adequately addressed in the letter, please contact by (email) TESrecall@tosoh.com or call Tosoh Technical Support (phone) 1-800-248-6764. Replenishment of Product: For replenishment of returned Testosterone test cups, please contact Customer Service department at 1-866-527-3587. Replenishments will be with ST AIA-PACK Testosterone Assay Test Cups from new lots Additional Information: In the event that 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, please contact Tosoh Technical Support (phone) 1-800-248-6764 (email) TESrecall@tosoh.com
• Quantity in Commerce: 310 units
• Distribution: Global Distribution. US Nationwide.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CDZ