Events

Retiro De Equipo (Recall) de Immucor MATCH IT! DNA Software version 3.29.0 (released 30 Jan 2018) for use with Allele Database used with LIFECODES HLA-B SSO Typing Kits. In vitro diagnostic medical devices.

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Abacus dx 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-2018-RN-00283-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2018-04-04
  • 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-2018-RN-00283-1
  • 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
    Abacus has been advised by immucor (the manufacturer), that as a result of a complaints investigation, it has been determined that the serological group for the b*27:08 allele was incorrectly assigned as bw4. the correct serological group assignment for b*27:08 is bw6. this assignment was part of the 3.29.0 allele database update. immucor confirm that there is no impact to the lifecodes hla-b sso typing kits themselves.Abacus technical support has confirmed that australian customers do not currently utilise this component of the software, however, are rectifying the issue so it does not present a hazard in the future.
  • Acción
    Abacus dx is advising that Immucor has created an executable file to correct the serological group assignment for B*27:08 when using the s.29.0 database update, which is available on the Immucor website. Customers are asked to upload this executable file before running LIFECODES HLA-B SSO typing kits. Instructions for uploading this file to correct the serological group alignment are outlined on the Customer Letter.

Device

Immucor MATCH IT! DNA Software version 3.29.0 (released 30 Jan 2018) for use with Allele Database...
  • Modelo / Serial
    Immucor MATCH IT! DNA Software version 3.29.0 (released 30 Jan 2018) for use with Allele Database used with LIFECODES HLA-B SSO Typing Kits. In vitro diagnostic medical devices.LIFECODES HLA-B SSO Typing Kit Affected Lots: 01117A (exp 30/11/2018) and 06036A (exp 31/05/2018)Typing Kit Catalogue Numbers: TL628915 and TL628915sARTG Numbers: 257272 , 217871
  • Manufacturer
    Abacus dx Pty Ltd

Manufacturer

Abacus dx Pty Ltd