Class 2 Device Recall FastPack Vitamin D Immunoassay

• Date Initiated by Firm: November 08, 2013
• Date Posted: December 19, 2013
• Recall Status: Terminated on September 18, 2014
• Recall Number: Z-0550-2014
• Recall Event ID: 66842
• 510(K)Number: K123983
• Product Classification: System, test, vitamin d - Product Code MRG
• Product: FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin D The FastPack Vitamin D Immunoassay is intended for the quantitative determination of 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.
• Code Information: Testosterone. Catalog Number 25000059. Lot Number 1309062-2P.Exp Date: 7/9/2014
• Recalling Firm/ Manufacturer: Qualigen Inc; 2042 Corte del Nogal; Carlsbad CA 92011-1438
• For Additional Information Contact: 760-918-9165
• 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: 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: 6
• 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MRG