Events

Retiro De Equipo (Recall) de Phadia AB Product EliA anti-TSH-R WellAn In Vitro Medical Device

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 ALS 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-00101-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2018-02-02
  • 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-00101-1
  • 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
    A malfunction of elia anti-tsh-r well carriers 14-5639-01 in lot 0014 has been discovered. the specified lot includes a limited number of carriers, where 8 or 16 wells in sequence will produce decreased response units (ru). out of 4122 carriers, to date 12 carriers have been identified giving this low ru pattern.To date, no adverse events have been reported. in australia these kits are currently used for evaluation purposes, not for generating patient results.This recall does not affect any other lots of elia anti-tsh-r or any other phadia products.
  • Acción
    Abacus ALS is advising affected users to quarantine any affected stock of the specified lot and discontinue use.

Device

Phadia AB Product EliA anti-TSH-R WellAn In Vitro Medical Device
  • Modelo / Serial
    Phadia AB Product EliA anti-TSH-R WellAn In Vitro Medical DeviceLot Number: 0014.Abacus ALS part number: PU14563901, Manufacturers part number: 14-5639-01ARTG Number: 229585 (Abacus ALS Pty Ltd - Clinical chemistry autoimmune IVDs)
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd