Events

Retiro De Equipo (Recall) de Bio-Rad D-10 Rack Loader

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 Biomet France SARL.

¿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
    19693
  • Fecha de inicio del evento
    2016-01-22
  • 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
    There is a potential for a sample and result to be mismatched when running in the d-10 rack loader configuration. this means that a patient result may be assigned to an incorrect sample id., while the manufacturer investigates and prepares a permanent solution, the recommendation is that customers verify that the number of results equals the total number of samples run. if there is a discrepancy, customers should identify the rack with the missing result, rerun all samples from that rack, and check the laboratory information system (lis) results.
  • Acción
    Manufacturer to issue advice regarding use

Device

Bio-Rad D-10 Rack Loader
  • Modelo / Serial
    Model: 220-0600, Affected: multiple items and batches
  • Manufacturer
    Biomet France SARL

Manufacturer

Biomet France SARL
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    NZMMDSA