Events

Retiro De Equipo (Recall) de Epiclone Anti-M Blood Grouping Reagent. 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 Seqirus 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-2017-RN-00817-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-11-17
  • 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-2017-RN-00817-1
  • 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
    The manufacturer merck-millipore has advised seqirus of an issue with anti-m monoclonal blood grouping reagents producing weak or negative testing results when testing m+ red blood cells in line with the method described in the instructions for use (ifu). seqirus sources these reagents as raw material items, which are then subject to acceptance testing and labelling / packaging and then distributed as seqirus epiclone anti-m. as part of batch release these materials passed all potency and specificity requirements, and there have not been any product technical complaints or market feedback of testing issues regarding these products.
  • Acción
    Seqirus is advising users to quarantine all affected stock from inventory. Seqirus will arrange collection of affected stock from customers.

Device

Epiclone Anti-M Blood Grouping Reagent. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Epiclone Anti-M Blood Grouping Reagent. An in vitro diagnostic medical device (IVD)Product Item Number: 00980501Pack Size: 1 unit per packLot Numbers: 009817001, 009817101 (exp 10/11/17), 009817201 (exp 11/11/17), 009817301, 009817401 (exp 09/12/19) and 009817501 (exp 05/12/19)ARTG: 225013
  • Manufacturer
    Seqirus Pty Ltd

Manufacturer

Seqirus Pty Ltd