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.
FDA Recall Z-0549-2014 · Posted 2013-12-19
Recalling FirmQualigen Inc
Recall StatusTerminated
Product CodeCEC
Date Initiated2013-11-08
Date Terminated2014-09-18
Product Quantity17
Reason for Recall
Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
Firm Action
Qualigen, Inc., notified customers of the recall by calling customers via telephone (with a telephone script) on 11/08/2013. The telephone (script) included the reason for recall, product description with codes, instructions and contact information. The customers were instructed to examine your inventory and discontinue use of the kits immediately. Qualigen will send you
replacement kits and provide you with a shipping label to return all of the defective kits including any that were partially used.
Feel free to contact System Support at 760.579.6900 if you have any
questions or require assistance with returning your kits.
Root Cause
Process change control
Distribution Pattern
US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.