Events

Rappel de Device Recall Hc2 System Software

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par QIAGEN Gaithersburg, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    57814
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1728-2011
  • Date de mise en oeuvre de l'événement
    2011-01-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-11-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97490
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Colorimeter, photometer, spectrophotometer for clinical use - Product Code JJQ
  • Cause
    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
  • Modèle / numéro de série
    hc2 User's Guide, Lots 5723098 and 5722169; and Qiagen embedded hc2 Software Suite 4.0, Lots Q50455 and Q50349.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    The recalled product was sold to medical laboratories nationwide and in Canada.
  • Description du dispositif
    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.
  • Adresse du fabricant
    QIAGEN Gaithersburg, Inc., 1201 Clopper Rd, Gaithersburg MD 20878-4000
  • Société-mère du fabricant (2017)
    QIAGEN N.V.
  • Source
    USFDA