Events

Rappel de Device Recall UniCel DxI 800 Access Immunoassay Systems

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 Beckman Coulter 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
    57952
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1938-2011
  • Date de mise en oeuvre de l'événement
    2011-01-26
  • Date de publication de l'événement
    2011-04-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-06-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97819
  • 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
    Analyzer chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Cause
    The recall was initiated due to beckman coulter receiving a report of results that were associated with incorrect patient identifications when two sample racks advanced into the sample presentation area in one push. the first rack of the two was not scanned. this is referred to as a "pushed pair." if a pushed pair event occurs, results may be associated with the incorrect patient identification.
  • Action
    Beckman Coulter sent an Urgent: Field Safety Notice Product Correction letter dated January 26, 2011, via US Postal Service to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: 1. To prevent a pushed pair, be sure your sample racks are free of debris prior to use. Do not apply additional labels to the sample racks. Extra labels can obscure the edges of a sample rack, or obstruct the gap between two racks. Be sure sample labels do not extend beyond the edges of a sample rack; 2. If a pushed pair occurs on the UniCel DxI system, the system generates a yellow Event Log message - Clear the presentation tray and press ROUTINE button. This Event Log message is associated with a variety of common Sample Presentation Unit (SPU) errors. For that reason, you must review the Event Log details to confirm the pushed pair event has not occurred; 3. Detach the Appendix included with this notification and store it near your UniCel DxI system. Use the Appendix as a reference if you suspect a pushed pair event has occurred on your system. Beckman Coulter also requested their customers share the recall information with their laboratory staff, and retain pages 1 and 2 of this notification as part of your laboratory Quality System documentation. For questions regarding ththe recall notification, customers were instructed to contact Beckman Coulter Customer Support Center on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support, or call 1-800-854-3633 in the United States or Canada. Outside the United States and Canada, contact their local Beckman Coulter Representative.

Device

Device Recall UniCel DxI 800 Access Immunoassay Systems
  • Modèle / numéro de série
    DxI System Software versions: 2.3, 2.4, 4.1, 4.2.1, 4.3 (Current released version), 4.3.2 (Released to a single Japanese customer only)
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Algeria, Angola, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Liechtenstein, Malaysia, Mayotte, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam.
  • Description du dispositif
    UniCel DxI 800 Access Immunoassay || Systems; Part Number(s): DxI 800: 973100, DxI 800 Remanufactured || A25288, DxI 800 with spot B A71456, DxI 800 || Reconditioned A25285 || The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Adresse du fabricant
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA