FDA-Device2013-12-25Class II
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.
Qualigen Inc
Hazard
Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
Sold states
US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.
Affected count
182
Manufactured in
2042 Corte del Nogal, N/A, Carlsbad, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0547-2014Don't want to check this manually?
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