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
USST 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
Recalling Firm: Tosoh Bioscience Inc
Reason for Recall / Hazard
TranslatedThe 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.
Product Description & Identification
TranslatedST 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
Additional Source Details
| Field | Value |
|---|---|
| City | Grove City |
| State | OH |
| Event id | 99210 |
| Address 1 | 3600 Gantz Rd |
| Code info | UDI-DI: 14560189210032; Lot Numbers: FX12404, FY12407, FY12406, FZ12408 |
| Postal code | 43123-1895 |
| Report date | 20260722 |
| Product type | Devices |
| Product quantity | 310 units |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260612 |
| Initial firm notification | Letter |
| Center classification date | 20260716 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human seru...?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Overview
- Recalling FirmTosoh Bioscience Inc
- StatusOngoing
- Risk LevelClass II
- DistributionGlobal Distribution. US Nationwide.
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🚨 SAFETY ALERT: 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 Check if your household is affected: https://therecallfile.com/recalls/st-aia-pack-testosterone-in-vitro-diagnostic-use-only-for-the-quantita/FDA-Z-2746-2026
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