ST AIA-PACK Testosterone N/ARecalls & reported problems
Tosoh Corporation · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- Jun 12, 2026Open, Classified
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.
Z-2746-2026 · Root cause: Component design/selection · Recall details · FDA record ↗
Other Radioimmunoassay, Testosterones And Dihydrotestosterone devices
- Access Testosterone 33560Beckman Coulter, Inc. · Radioimmunoassay, Testosterones And Dihydrotestosterone1 recall16 reports
- Salivary Testosterone ELISA SLV-3013DRG Instruments Gesellschaft mit beschränkter Haftung · Radioimmunoassay, Testosterones And Dihydrotestosterone1 recall0 reports
- IMMULITE®/IMMULITE® 1000 Systems TES Total Testosterone 10381156Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE1 recall0 reports
- Elecsys Testosterone II 08946370190Roche Diagnostics GmbH · RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE19 reports
- Elecsys Testosterone II 08946353190Roche Diagnostics GmbH · RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE6 reports
- Elecsys Testosterone II 07027915190Roche Diagnostics GmbH · RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE4 reports
- Elecsys SHBG 07258496190Roche Diagnostics GmbH · RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE1 report
- Elecsys SHBG 3052001160Roche Diagnostics GmbH · RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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