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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 Device Recall FastPack Total PSA Immunoassay see related information
Date Initiated by Firm September 29, 2008
Date Posted December 22, 2008
Recall Status1 Terminated 3 on June 02, 2011
Recall Number Z-0500-2009
Recall Event ID 50115
510(K)Number K994419  
Product Classification Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers - Product Code LTJ
Product FastPack(R) Total PSA Immunoassay; Catalog #: 25000001

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(R) Total PSA immunoassay is designed for use with the FastPack (R) System.
Code Information Lot Numbers: 0807002-901, 0807002-903, 0807002-904, 0807002-905, 0807002-906, 0807002-907, 0807002-908, and 0807002-909.
Recalling Firm/
Manufacturer		 Qualigen Inc
2042 Corte del Nogal
Carlsbad CA 92011-1438
For Additional Information Contact
760-918-9165
Manufacturer Reason
for Recall		 The recall was initiated after the firm investigation of customer complaints of falsely elevated results determined the product was not meeting product performance expectations.
FDA Determined
Cause 2		 Other
Action The recall was initiated with Qualigen faxing a copy of the Product Notification letter, dated 9/29/2008, to all customers who have received any sublot of the affected product . Faxes were sent beginning 9/29/08. The recall letter informed the customers that the affected product was not meeting the firm's expectations for product performance. Customers were instructed to please stop using the affected lots immediately as they have been noted to produce falsely elevated results and they should confirm any result that appears to be inconsistent with "a patient's medical history, clinical examination, and other findings". In addition, they may wish to retest any patients that were run with a different FastPack lot. Beginning on 9/30/08, all customers were contacted by phone to confirm that they received the recall letter. The customers were shipped replacement products at no cost and as part of the product replacement process, they were instructed to return any unused Total PSA FastPacks/Kits of lot 0807002 to Qualigen.
Quantity in Commerce 720 kits
Distribution Worldwide Distribution --- including USA and countries of Canada, UK , Italy, Switzerland, Sweden, & South Korea.
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 = LTJ and Original Applicant = QUALISYS DIAGNOSTICS, INC.
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