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U.S. Department of Health and Human Services

Class 2 Device Recall FastPack System Complete Immunoassay Kit

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  Class 2 Device Recall FastPack System Complete Immunoassay Kit see related information
Date Initiated by Firm November 06, 2019
Create Date April 06, 2020
Recall Status1 Terminated 3 on September 23, 2020
Recall Number Z-1672-2020
Recall Event ID 85134
510(K)Number K182521  
Product Classification Radioimmunoassay, testosterones and dihydrotestosterone - Product Code CDZ
Product The FastPack System Comlete Immunoassay Kit

Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack System. The FastPack IP SHBG assay is intended for use as an aid in the diagnosis of androgen disorders.

Each Kit Contains
30 FastPack IP SHBG Immunoassays
1 Calibrator 1 x 3 mL Vial
1 Control 1 1 x 3 mL Vial
1 Control 2 1 x 3 mL Vials
32 Sample Diluent 0.9 mL Vials

REF 25000081
IVD
CE

1908038-1P
2020-02-22
(01) 20816467020345
(17) 200222
(10) 1908038-1P
Code Information 1908038-1P 2020-02-22 (01) 20816467020345 (17) 200222 (10) 1908038-1P
Recalling Firm/
Manufacturer		 Qualigen Inc
2042 Corte Del Nogal
Carlsbad CA 92011-1438
For Additional Information Contact Ben Abugan
760-918-9165 Ext. 237
Manufacturer Reason
for Recall		 The chemiluminescent immunoassay has been noted to have higher than expected results which may result in inaccurate quantitative determinations of Sex Hormone Binding Globulin in human serum and plasma.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On October 31, 2019, a "Urgent: Product Recall" letter was sent to customer via E-Mail. In addition to informing consignees about the recall the customer notification asked consignees to take the following actions: 1. The firm will provide replacement kits at no cost as soon as they become available. 2. For any kits that have been purchased a refund can be requested in place of replacement kits. 3. As part of the product replacement process, please confirm that any remaining SHBG FastPacks/Kits of Lot Number 1908038-1P have been discarded on the form below. 4. The firm will call to confirm that you have received the letter and provide any additional details you may require. For questions, please contact System Support at systemsupport@qualigeninc.com.
Quantity in Commerce 24 Kits (30 test packs each) 720 tests
Distribution US Nationwide distribution in the states of AL, AK, CA, HI, and TX.
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 = CDZ and Original Applicant = Qualigen, Inc.
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