Events

Retiro De Equipo (Recall) de MATCH IT TM DNA SOFTWARE V 1.2

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por IMMUCOR GTI DIAGNOSTICS INC..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    44984
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2018-02-11
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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
  • Modelo / Serial
    Model Catalog: 888623 (Lot serial: NA)
  • Descripción del producto
    MATCH IT! DNA SOFTWARE
  • Manufacturer
    IMMUCOR GTI DIAGNOSTICS INC.

Manufacturer

IMMUCOR GTI DIAGNOSTICS INC.
  • Dirección del fabricante
    WAUKESHA
  • Empresa matriz del fabricante (2017)
    Hologic, Inc.
  • Source
    HC