Recall Z-1728-2011 ยท JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
QIAGEN Gaithersburg, Inc.
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: d
| Date | Jan 12, 2011 |
| Status | Terminated |
| Reason | The software component of a diagnostic medical device may be defective and could cause incorrect patient values. |
| 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 techservice-na@qiagen.com. The firm informed users that they will provide further detailed instructions for a |
| Quantity | 163 |
| Distribution | The recalled product was sold to medical laboratories nationwide and in Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980120 | DIGENE DML 2000 MICROPLATE LUMINOMETER Digene Corp., Feb 6, 1998 |