Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone Recalled by Qualigen Inc Due to Qualigen initiated this recall because the FastPack kit...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Qualigen Inc directly.
Affected Products
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.
Quantity: 18
Why Was This Recalled?
Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
Where Was This Sold?
This product was distributed to 16 states: AL, CA, IN, KS, KY, MA, NV, NY, NC, OK, SC, TN, TX, UT, VA, WA
About Qualigen Inc
Qualigen Inc has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report