Events

Retiro De Equipo (Recall) de LABType DNA Typing Tests (for transplant compatibility analysis). An in vitro diagnostic medical device (IVD).

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Bio-Strategy Pty Ltd.

¿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
    RC-2016-RN-01380-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-05-17
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01380-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Lot specific user documents and catalog files updated for the january 2016 nomenclature contain incorrect allele specificity information for certain beads for particular labtype dna typing tests. the affected documents and catalog files were accessible between the date period july 29, 2016 to august 22, 2016.
  • Acción
    Bio-Strategy has provided customers with corrected lot-specific user documents and catalog files, and advised that results obtained using the affected products and incorrect user documents and catalog files should be reviewed using the corrected information. This action has been closed-out on 17/05/2017.

Device

LABType DNA Typing Tests (for transplant compatibility analysis). An in vitro diagnostic medical ...
  • Modelo / Serial
    LABType DNA Typing Tests (for transplant compatibility analysis). An in vitro diagnostic medical device (IVD).SSO Class II DRB1 (Catalog ID: RSSO2B1, RS02B1T)HD Class II DRB1 (ID: RSSOH2B1, RSOH2B1T, RSSOH2B1X)SSO Class II DQA1/DQB1 (ID: RSSO2Q, RSSO2QX, RSO2QT)SSO MICA (ID: RSSOMICA)SSO Class I Bw4 Supplement (ID: RSSO1S4, RSO1S4T)XR Class II DRB1 (ID: RSSOX2B1, RSOX2B1T)CWD Class II DRB1 (ID: RSSOW2B1, RSOW2B1T)Multiple lots affected.ARTG Numbers: 236737 & 236738
  • Manufacturer
    Bio-Strategy Pty Ltd

Manufacturer

Bio-Strategy Pty Ltd