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U.S. Department of Health and Human Services

Class 2 Device Recall FastPack Total PSA Immunoassay

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 Class 2 Recall
FastPack Total PSA Immunoassay
see related information
Date Posted December 19, 2013
Recall Status1 Open
Recall Number Z-0547-2014
Recall Event ID 66842
Premarket Notification
510(K) Number
K994419 
Product Classification Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers - Product Code LTJ
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.
Code Information Total PSA: Catalog Number 25000040. Lot Number 1309038-10P Exp Date 6/26/2013.
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 182
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 = LTJ and Original Applicant = QUALISYS DIAGNOSTICS, INC.
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