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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
FastPack® Free T4 Immunoassay FastPack® Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin D 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. Testosterone. Catalog Number 25000059. Lot Number 1309062-2P.Exp Date: 7/9/2014 Class II Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. 6 Z-0550-2014
FastPack® Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 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. Testosterone. Catalog Number 25000043. Lot Number 1310028-2P.Exp Date: 4/10/2014 Class II Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. 17 Z-0549-2014
FastPack® Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone 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. Testosterone. Catalog Number 25000041. Lot Number 1310019-3P Exp Date: 9/22/2014 Class II Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. 18 Z-0548-2014
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. Total PSA: Catalog Number 25000040. Lot Number 1309038-10P Exp Date 6/26/2013. Class II Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. 182 Z-0547-2014
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