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U.S. Department of Health and Human Services

Class 2 Device Recall FastPack Testosterone Immunoassay

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 Class 2 Recall
FastPack Testosterone Immunoassay
see related information
Date Posted December 19, 2013
Recall Status1 Open
Recall Number Z-0548-2014
Recall Event ID 66842
Premarket Notification
510(K) Number
K021972 
Product Classification Radioimmunoassay, Testosterones And Dihydrotestosterone - Product Code CDZ
Product FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended strictly for in-vitro diagnostic use as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. The FastPack Testo Immunoassay is designed for use with the FastPack System.
Code Information Testosterone. Catalog Number 25000041. Lot Number 1310019-3P Exp Date: 9/22/2014
Recalling Firm/
Manufacturer
Qualigen Inc
2042 Corte del Nogal
Carlsbad, California 92011-1438
Manufacturer Reason
for Recall
Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control
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.
Quantity in Commerce 18
Distribution US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CDZ and Original Applicant = QUALIGEN, INC.
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