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Qualigen Inc recalls FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoa
Recalled December 25, 2013 · FDA recall Z-0547-2014 · 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
182
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 Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack Total PSA 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 →