FDA Device recall Z-2746-2026
ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AI…
- FDA Device
- Class II
- ongoing
- Published 2026-07-22
On 2026-07-22 the FDA classified a Class II recall of ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AI… by Tosoh Bioscience, citing 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 elevate….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2746-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-12 |
| Published | 2026-07-22 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Tosoh Bioscience |
| Distribution | US |
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
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.
Identifiers
| code_info | UDI-DI: 14560189210032; Lot Numbers: FX12404, FY12407, FY12406, FZ12408 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2746-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.