Events

Retiro De Equipo (Recall) de ID-DiaCell ABO

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Bio-Rad Laboratories 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
    21117
  • Fecha de inicio del evento
    2017-02-28
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Bio-Rad Laboratories Ltd, 189 Bush Road, Rosedale, AUCKLAND 0632
  • Causa
    The manufacturer has become aware of unexpected reactions primarily on eluates and qc samples but also with some patient samples when using the id-diacell l-ll-lll and id-diapanel products. in case of doubtful reactions, please re-test with a new kit. if the results remain in doubt, the manufacturer advises to send the sample to a reference laboratory and if an urgent transfusion is required, perform a crossmatch., follow up 24 feb 2017: there has been further development (follow up) from our manufacturer additional 3 other devices that are also affected., the manufacturer received complaints regarding indirect antiglobulin test (iat), especially when eluates and qc samples were tested, less frequently when patient samples were tested.
  • Acción
    Manufacturer to issue advice regarding use

Device

ID-DiaCell ABO
  • Modelo / Serial
    Model: , Affected: ID-DiaCell IP-IIP-IIIP, ID-DiaScreen VP-VIP, ID-DiaPanel-P, All lots currently in date
  • Manufacturer
    Bio-Rad Laboratories Inc

Manufacturer

Bio-Rad Laboratories Inc