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

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.

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.