Class 2 Device Recall

• Date Initiated by Firm: May 28, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on November 23, 2004
• Recall Number: Z-1039-04
• Recall Event ID: 29292
• Product Classification: Dna-Reagents, Cytomegalovirus - Product Code LSO
• Product: Digene Hybrid Capture System CMV DNA Test (version 2.0), packaged in a cardboard box containing test reagents for performing 60 tests. Digene Catalog #4403-2003.
• Code Information: Lot number 6234, EXP 10/20/04
• FEI Number: 3003572099
• Recalling Firm/ Manufacturer: Digene Corp; 1201 Clopper Rd; Gaithersburg MD 20878-4000
• For Additional Information Contact: Donna Sowers; 301-944-7007
• Manufacturer Reason for Recall: In vitro diagnostic test kit may produce false negative clinical results.
• FDA Determined Cause: Other
• Action: The recalling firm notified consignees by phone 5/28/04 and by faxed letter 6/2/04. The letter advised of possible false negative test results and that such results should be retested immediately with replacement kits provided by the firm. The notification further advised that positive results should be considered valid if the assay meets all verification and calibration criteria. Consignees were requested to return product and response form.
• Quantity in Commerce: 206 kits
• Distribution: Product was sold to medical facility clinical laboratories nationwide and a distributor in the United Kingdom.
• 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.