Events

Retiro De Equipo (Recall) de UNICEL DXH SLIDEMAKER STAINER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BECKMAN COULTER CANADA L.P..

¿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
    107595
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-10-04
  • 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
    The dxh sms with software version 1.5.1.0 will not read codabar labels at the primary barcode reader when the aim-16 checksum digit calculation is used with any leading and trailing characters that are not both "a" (e.G. a12345b). the codabar barcode symbology uses a single leading and trailing character as start and stop indicators with characters such as a b c or d. when the codabar symbology is used the labels can contain either matching or non-matching start and stop characters. if the character a is used for both the start and stop character (i.E.A12345a) the dxh sms will read the bar code label successfully. if any other start and stop characters are used the system will produce no read from the primary barcode reader.

Device

UNICEL DXH SLIDEMAKER STAINER
  • Modelo / Serial
    Model Catalog: 775222 (Lot serial: > 10 numbers contact mfg)
  • Descripción del producto
    UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM PN 775222
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    HC