Events

Rappel de MATCH IT TM DNA SOFTWARE V 1.2

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par IMMUCOR GTI DIAGNOSTICS 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
    44984
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2018-02-11
  • 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
    It has been determined that when using match it! dna software v1.2.3 (with the pairwise functionality turned off) on a win 7 32-bit computer to analyze hla-a typing the software does not correctly load the suggested assignment table when navigating between samples that contain complex numbers of hla-a allele-string pairs. when the user navigates from one sample to the next the software does not automatically assign a typing into the assigned view field when the auto assign feature is activated in preferences. if the user attempts to make a manual assignment to the assigned view field the software will crash. it has also been determined that there is a possibility of a mistype when using match it! dna software v1.2.4 (with the pairwise functionality turned off) on a win 7 32-bit computer to analyze hla-a typing. if the user navigates from one sample to the next sample the software can maintain the previous sample typing in the assigned view field in addition to the suggested assignments. if the user attempts to make a manual assignment the software will freeze. there is no warning that the typing in assigned view is incorrect.

Device

MATCH IT TM DNA SOFTWARE V 1.2
  • Modèle / numéro de série
    Model Catalog: 888623 (Lot serial: NA)
  • Description du dispositif
    MATCH IT! DNA SOFTWARE
  • Manufacturer
    IMMUCOR GTI DIAGNOSTICS INC.

Manufacturer

IMMUCOR GTI DIAGNOSTICS INC.
  • Adresse du fabricant
    WAUKESHA
  • Société-mère du fabricant (2017)
    Hologic, Inc.
  • Source
    HC