Events

Rappel de UNICEL DXC 880I SYNCHRON ACCESS CLINICAL ANALYZER

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BECKMAN COULTER CANADA L.P..

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
    27982
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2013-03-20
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notes supplémentaires dans les données
  • Cause
    1. when archiving to a usb flash drive if the calibrator name contains the forward slash "/" character the calibration report will not be archived for the affected calibrators. there is no warning or message to tell the customer that the calibration report has not been archived. calibrator archive reports for these calibrations are not created and the calibration information is not available to download to the usb flash drive. calibrators affected: iron/ibct lx/dxc apo (lx/dxc apo cal on the cal disk) lx/dxc ma lx/dxc pab. 2. when upgrading from one version of 5.0 to another the calibration files that are older than the most recent five calibrations but have not been archived to the usb flash drive are not transitioned to the new version of software. as a result these calibration files are not available to download to the usb flash drive after the upgrade. this issue also affects a "parallel upgrade" in which the same version of 5.0 software is reinstalled on the system.

Device

UNICEL DXC 880I SYNCHRON ACCESS CLINICAL ANALYZER
  • Modèle / numéro de série
    Model Catalog: A59102 (Lot serial: 4143); Model Catalog: 4768 (Lot serial: 4143); Model Catalog: A59102 (Lot serial: 3563); Model Catalog: 4768 (Lot serial: 3563); Model Catalog: A59102 (Lot serial: 2788); Model Catalog: 4768 (Lot serial: 2788); Model Catalog: 4764 (Lot serial: > 10 numbers contact mfg); Model Catalog: A11816 (Lot serial: > 10 numbers contact mfg); Model Catalog: A64935 (Lot serial: 4282); Model Catalog: 4773 (Lot serial: 4282); Model Catalog: 4767 (Lot serial: > 10 numbers contact mfg); Model Catalog: A10405 (Lot serial: > 10 numbers contact mfg); Model Catalog: A27318 (Lot serial: > 10 numbers contact mfg)
  • Description du dispositif
    UNICEL DXC 880I SYNCHRON ACCESS CLINICAL ANALYZER
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.