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Qualigen Inc recalls FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Im
Recalled December 25, 2013 · FDA recall Z-0548-2014 · Qualigen
Hazard
Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. · FDA Class II
Units
18
Sold at
US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.
Description
Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
Product
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.
Manufacturer(s)
Qualigen Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →