Events

Rappel de Device Recall Access 2 Immunoassay System

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
    76688
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1709-2017
  • Date de mise en oeuvre de l'événement
    2017-03-07
  • Date de publication de l'événement
    2017-03-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-03-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153845
  • 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
    Beckman coulter is recalling the access 2 family of immunoassay systems because a circuit board that controls motor functions can affect device positioning on the pipettor and incubator belt while the instrument is running. the position errors cause the instrument to stop running and cancel tests that are in process.
  • Action
    An Urgent Medical Device Recall letter was sent on 3/7/17 to inform customers that Beckman Coulter has determined through internal investigation that a circuit board that controls motor functions in the instrument systems listed above can affect device positioning on the pipettor and incubator belt while the instrument is running. Customers are informed of the impact, action to be taken, and the resolution. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions are instructed to contact Customer Technical Support Center: ¿ From our website: http://www.beckmancoulter.com ¿ By phone: call 1-800-854-3633 in the United States and Canada. ¿ Outside the United States and Canada, contact your local Beckman Coulter representative.

Device

Device Recall Access 2 Immunoassay System
  • Modèle / numéro de série
    Serial No. 511527 - 511678; 511681 - 512212
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Affected geographies: Algeria, Austria, Australia, Bangladesh, Bulgaria, Brazil, Canada, China, Costa Rica, Cyprus, Colombia, Czech Republic, El Salvador, France, Germany, Ghana, Greece, Guatemala, India, Indonesia, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Lithuania, Malawi, Mexico, Morocco, Myanmar, Nepal, Oman, Panama, Philippines, Pakistan, Paraguay, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, South Korea, Spain, Switzerland, Tunisia, Turkey, United Kingdom, United States, Vietnam, Zimbabwe
  • Description du dispositif
    Access 2 Immunoassay Systems, Part No. 81600N || Product Usage: || The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices 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., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA