Events

Retiro De Equipo (Recall) de DiaClon ABO/D+ Reverse Grouping for Patients. 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-Rad Laboratories 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-00321-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2018-04-24
  • 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-00321-1
  • 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
    Bio-rad have been made aware that a limited amount of id-cards diaclon abo/d + reverse grouping for patients, lot 50093 87 17, were packed in boxes stating a storage temperature range of 2-8°c on the outer carton instead of 18-25°c for this product.The product label shows the correct storage conditions for this product. this issue has no impact on product used prior to may 1 2018.
  • Acción
    Bio-Rad is advising users to inspect their inventory to confirm that the affected lot has been stored between 18-25°C and not 2-8°C. If for any reason the product is stored at 2-8°C, please discard product after 1st May 2018.

Device

DiaClon ABO/D+ Reverse Grouping for Patients. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    DiaClon ABO/D+ Reverse Grouping for Patients. An in vitro diagnostic medical device (IVD).Catalogue Number: 001267Displayed Lot Number: 50093 87 17SAP Lot Number: 2201808717Expiry Date: 31/01/2019ARTG Number: 212527
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd