Class 2 Device Recall

• Date Initiated by Firm: February 07, 2003
• Date Posted: March 19, 2003
• Recall Status: Terminated on July 16, 2003
• Recall Number: Z-0657-03
• Recall Event ID: 25678
• 510(K)Number: K990023
• Product Classification: Kit, Dna Detection, Human Papillomavirus - Product Code MAQ
• Product: Hybrid Capture II CT-ID Test, Catalog #5135-1050IVT, (labeled for export only).
• Code Information: Lot 2443/ exp 2002-12-02
• Recalling Firm/ Manufacturer: 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: Other
• 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: 272 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.

• 510(K) Database: 510(K)s with Product Code = MAQ