FDA-Device2013-12-25Class II
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.
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
17
Manufactured in
2042 Corte del Nogal, N/A, Carlsbad, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0549-2014Don't want to check this manually?
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