06

Apr

2011

Cl ll Hc2 System Software

0

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

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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