Tosoh Bioscience Inc recalls ST AIA-Pack Testosterone

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.

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

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 TESrecall@tosoh.com 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 TESrecall@tosoh.com 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.

• FDA enforcement recordOfficial FDA database entry for Z-2746-2026
• FDA 510(k) clearance · K023091The device's official FDA premarket clearance record
• FDA device classification · CDZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.1680The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Tosoh Bioscience IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.