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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm February 07, 2003
Date Posted March 19, 2003
Recall Status1 Terminated 3 on July 16, 2003
Recall Number Z-0655-03
Recall Event ID 25678
PMA Number P890064S006 
Product Classification Kit, Dna Detection, Human Papillomavirus - Product Code MAQ
Product Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5196-1230, labeled for export only.
Code Information Lot 2759/ exp 2003-08-31
Recalling Firm/
Digene Corp
1201 Clopper Road
Gaithersburg MD 20878
For Additional Information Contact Digene Technical Services
800-344-3631 Ext. 1
Manufacturer Reason
for Recall
In Vitro diagnostic test kit may produce false positive patient results
FDA Determined
Cause 2
Action The firm notified consignees by phone and fax 2/7/03 and advised of potential for false positive patient results. Firms were instructed to destroy remaining inventory for replacement. Consignees were asked to return response form.
Quantity in Commerce 848 kits/ 96 assays per kit
Distribution Domestic product was sold to distributors and end users nationwide and to foreign consignees in Barbados and Spain. Product labeled for export only was distributed to Belgium, Brazil, France, Italy, Portugal, Russia, Slovenia, Spain, Switzerland, Germany and the UK. Firm estimates that 40% of distributed product may remain in user channels.
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.
PMA Database PMAs with Product Code = MAQ and Original Applicant = QIAGEN GAITHERSBURG, INC