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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Product Detail

Product Description FastPack® Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. 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.
Recall Number Z-0547-2014
Classification Class II
Code Info Total PSA: Catalog Number 25000040. Lot Number 1309038-10P Exp Date 6/26/2013.
Product Distributed Qty 182
Reason For Recall Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.

Event Detail

Event Id 66842
Product Type Devices
Status Ongoing
Recalling Firm Qualigen Inc
City Carlsbad
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-08
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.