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Qualigen Inc recalls FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastPack free T4 Immunoas
Recalled December 25, 2013 · FDA recall Z-0549-2014 · 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
17
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 Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastPack free T4 Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of FT4 in human serum. The FastPack free T4 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 →