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U.S. Department of Health and Human Services

Class 2 Device Recall Hc2 System Software

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  Class 2 Device Recall Hc2 System Software see related information
Date Initiated by Firm January 12, 2011
Create Date June 26, 2015
Recall Status1 Terminated 3 on November 14, 2011
Recall Number Z-1728-2011
Recall Event ID 57814
510(K)Number K980120  
Product Classification Colorimeter, photometer, spectrophotometer for clinical use - Product Code JJQ
Product Hc2 System Software Suite 4.0 version 3.0, available as component in Qiagen user guide, catalog #5050-00162, and as a component within a Qiagen PC, available as catalog # 5050-11140A.

The software calculates and interprets assay results generated by the Digene Microplate Luminometer according to assay validation parameters. The software is used in conjunction with the following QIAGEN products: digene HC2 High-Risk HPV DNA Test [5199-1220 (one-plate); 5199-00016 (four-plate)] digene HC2 HPV DNA Test (5198-1220) digene HC2 CT/GC DNA Test (5130-1220) digene HC2 CT-ID DNA Test (5135-1220) digene HC2 GC-ID DNA Test (5140-1220) digene HC2 CT-GC Dual-ID DNA Test (5145-1220)
Code Information hc2 User's Guide, Lots 5723098 and 5722169; and Qiagen embedded hc2 Software Suite 4.0, Lots Q50455 and Q50349.
Recalling Firm/
Manufacturer		 QIAGEN Gaithersburg, Inc.
1201 Clopper Rd
Gaithersburg MD 20878-4000
For Additional Information Contact Qiagen Technical Services
800-344-3631 Ext. 2
Manufacturer Reason
for Recall		 The software component of a diagnostic medical device may be defective and could cause incorrect patient values.
FDA Determined
Cause 2		 Software design
Action The firm, Qiagen, sent a "Notice of Product Field Action" letter dated January 12, 2011 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue the process of running multiple assay protocols on a single microplate to eliminate the potential for inaccurate patient result reporting, and to complete and return the acknowledgment section via fax to QIAGEN 661-702-3854 or scan the document and email to techservice-na@qiagen.com. The firm informed users that they will provide further detailed instructions for a workaround and software fix. A QIAGEN representative will contact the customers who indicated that they run multiple assays on a plate and are currently using the HC2 System Software Version 3.0 (Suite 4.0), to assist in the identification of those patients that may have been affected by the software defect. If you have any questions or concerns, please contact Qiagen Technical Services at 800-344-3631, Option 2.
Quantity in Commerce 163
Distribution The recalled product was sold to medical laboratories nationwide and in Canada.
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 = JJQ and Original Applicant = DIGENE CORP.
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