Recall Z-2746-2026 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Tosoh Bioscience Inc
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
| Date | Jul 16, 2026 (initiated Jun 12, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Component design/selection |
| Action | 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 |
| Quantity | 310 units |
| Distribution | Global Distribution. US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023091 | ST AIA-PACK TESTOSTERONE ASSAY Tosoh Medics, Inc., Dec 17, 2002 |