Events

Recall of Device Recall Hc2 System Software

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by QIAGEN Gaithersburg, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    57814
  • Event Risk Class
    Class 2
  • Event Number
    Z-1728-2011
  • Event Initiated Date
    2011-01-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97490
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Colorimeter, photometer, spectrophotometer for clinical use - Product Code JJQ
  • Reason
    The software component of a diagnostic medical device may be defective and could cause incorrect patient values.
  • 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.

Device

Device Recall Hc2 System Software
  • Model / Serial
    hc2 User's Guide, Lots 5723098 and 5722169; and Qiagen embedded hc2 Software Suite 4.0, Lots Q50455 and Q50349.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The recalled product was sold to medical laboratories nationwide and in Canada.
  • Product Description
    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)
  • Manufacturer
    QIAGEN Gaithersburg, Inc.

Manufacturer

QIAGEN Gaithersburg, Inc.
  • Manufacturer Address
    QIAGEN Gaithersburg, Inc., 1201 Clopper Rd, Gaithersburg MD 20878-4000
  • Manufacturer Parent Company (2017)
    QIAGEN N.V.
  • Source
    USFDA