Z-1728-2011

Hc2 System Software Suite 4.0 version 3.0, available as component in Qiagen user guide, catalog #5050-00162...

Name: Z-1728-2011 Hc2 System Software Suite 4.0 version 3.0, available as component in Qiagen user guide, catalog #5050-00162...
Creator: QIAGEN Gaithersburg, Inc.
Published: 2011-01-12
License: https://open.fda.gov/license/

Qiagen / initiated 2011-01-12 / Terminated / root cause: software

FDA source

QIAGEN Gaithersburg, Inc. began a recall of 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... on 2011-01-12. The reason FDA records is "The software component of a diagnostic medical device may be defective and could cause incorrect patient values". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1728-2011
Status: Terminated
Initiated: 2011-01-12
Posted: 2015-06-26
Terminated: 2011-11-14
Recalling firm: Qiagen
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)
Product code: JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Reason for recall: The software component of a diagnostic medical device may be defective and could cause incorrect patient values.
Root cause tag: software
FDA root cause: 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 [email protected]. 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.
Product codes and lots: hc2 User's Guide, Lots 5723098 and 5722169; and Qiagen embedded hc2 Software Suite 4.0, Lots Q50455 and Q50349.

Product code JJQ

K980120Class IDigene Dml 2000 Microplate LuminometerDigene Corp. / cleared 1998-02-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)