Recall Z-2746-2026

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 taken

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