Events

Rappel de Device Recall CXP Analysis 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 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
    37083
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0420-2007
  • Date de mise en oeuvre de l'événement
    2006-08-29
  • Date de publication de l'événement
    2007-02-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49967
  • 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
    cell analyzer software - Product Code GKZ
  • Cause
    Two workflow scenarios associated with renaming regions may produce incorrect results.
  • Action
    A Product Corrective Action (PCA) letter was sent on the week of August 29, 2006 to all accounts that have an FC500 or have ordered CXP or MXP software to inform them that a) incorrect statistics are generated when a polygonal region with vertical re-entrant vertices is renamed using the Region Properties dialog box. b)when a region is copied from one plot to another, and then the new region is renamed, the statistics are not updated with the new region name. (Letter was sent by US mail). Letter includes immediate user preventive action to remedy both issues. A response form is included for consignees to return to recalling firm.

Device

Device Recall CXP Analysis Software
  • Modèle / numéro de série
    Part Numbers: 722396, 722395, 722397, 722398, 722399,  722593, 722594, 722595, 629640, 629639, 629641, 629642,  629643, 629644, 629645, 629646.  Software, Versions 2.0 & 2.1
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide & Canada
  • Description du dispositif
    CXP Analysis Software, Versions 2.0 & 2.1: Part #722396 CXP Analysis Software Kit V2.1, Single User; Part #722395 CXP Analysis Software Kit V2.1, Single User Upgrade; Part #722397 CXP Analysis Software Kit V2.1, 3 User Pack; Part #722398 CXP Analysis Software Kit V2.1, 5 User Pack; Part #722399 CXP Analysis Software Kit V2. 1, 15 User Pack; Part # || 722593 CXP Analysis Software Kit V2.1, 5 Network User Pack || Part #722594 CXP Analysis Software Kit V2.1, 10 Network User Pack; Part #722595 CXP Analysis Software Kit V2.1, 15 Network User Pack; Part #629640 CXP Analysis Software Kit V2.0, Single User; Part #629639 CXP Analysis Software Kit V2.0, Single User Upgrade; Part #629641 CXP Analysis Software Kit V2.0, 3 User Pack; Part #629642 CXP Analysis Software Kit V2.0, 5 User Pack; Part #629643 CXP Analysis Software Kit V2.0, 15 User Pack; Part #629644 CXP Analysis Software Kit V2.0, 5 Network User Pack; Part #629645 CXP Analysis Software Kit V2.0, 10 Network User Pack; Part #629646 CXP Analysis Software Kit V2.0, 15 Network User Pack. The Cytomics FC 500 is a system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles.
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc
  • Adresse du fabricant
    Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
  • Source
    USFDA