FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone ...
FDA Device Recall #Z-0548-2014 — Class II — November 8, 2013
Recall Summary
| Recall Number | Z-0548-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 8, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Qualigen Inc |
| Location | Carlsbad, CA |
| Product Type | Devices |
| Quantity | 18 |
Product Description
FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended strictly for in-vitro diagnostic use as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. The FastPack Testo Immunoassay is designed for use with the FastPack System.
Reason for Recall
Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
Distribution Pattern
US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.
Lot / Code Information
Testosterone. Catalog Number 25000041. Lot Number 1310019-3P Exp Date: 9/22/2014
Other Recalls from Qualigen Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0805-2025 | Class III | The FastPack IP Sex Hormone Binding Globulin Im... | Dec 3, 2024 |
| Z-0022-2025 | Class II | FastPack TSH Calibrator Kit, REF: 25000024, For... | Aug 26, 2024 |
| Z-1672-2020 | Class II | The FastPack System Comlete Immunoassay Kit ... | Nov 6, 2019 |
| Z-3112-2017 | Class II | Qualigen(R) The FastPack(R) IP Vitamin D Comple... | Jul 7, 2017 |
| Z-0550-2014 | Class II | FastPack Free T4 Immunoassay FastPack Vitamin... | Nov 8, 2013 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.