Company: QIAGEN
Date of Enforcement Report 4/6/2011
Class ll:
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). a) hc2 User’s Guide, and b) Qiagen embedded hc2 Software Suite 4.0. Recall # Z-1728-2011
REASON
The software component of a diagnostic medical device may be defective and could cause incorrect patient values.
RECALLING FIRM/MANUFACTURER
QIAGEN Gaithersburg, Inc., Gaithersburg, MD, by letter dated January 12, 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
163 units
DISTRIBUTION
Nationwide and Canada
