Events

Retiro De Equipo (Recall) de ARCHITECT Free T4 Reagent. An in vitro diagnostic medical device (IVD)List Numbers: 7K65-29 (100 Test Kit), 7K65-34 (2000 Test Kit) and 7K65-39 (500 Test Kit)Multiple Lot Numbers (see attached)ARTG Number: 180112

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Abbott Australasia Pty Ltd Diagnostic Division.

¿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-00562-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-05-02
  • 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-2017-RN-00562-1
  • 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
    Abbott diagnostics is providing information regarding a change of measuring interval for the architect free t4 assay list numbers 7k65-29, 7k65-34 and 7k65-39.The current measuring interval is 0.40 ng/dl (5.15 pmol/l) to 6.00 ng/dl (77.22 pmol/l).Recent data generated by abbott have determined that the measuring interval is 0.40 ng/dl (5.15 pmol/l) to 5.00 ng/dl (64.35 pmol/l). this new measuring range will be included in a future version of the instructions for use and the new ft4 assay file. there is no impact to patient results with values between 0.40 ng/dl (5.15 pmol/l) and 5.0 ng/dl (64.35 pmol/l). only the measuring interval between 5.00 – 6.00 ng/dl (64.35 – 77.22 pmol/l) is affected.
  • Acción
    Abbott is advising users that patient sample results between 5.00 ng/dL (64.35 pmol/L) and 6.00 ng/dL (77.22pmol/L) should be reported as >5.00 ng/dL (64.35pmol/L). In addition, the customer letter should be reviewed with the laboratory’s management for potential impact specific to laboratory procedures such as internal ranges.

Device

ARCHITECT Free T4 Reagent. An in vitro diagnostic medical device (IVD)List Numbers: 7K65-29 (100 ...
  • Modelo / Serial
    ARCHITECT Free T4 Reagent. An in vitro diagnostic medical device (IVD)List Numbers: 7K65-29 (100 Test Kit), 7K65-34 (2000 Test Kit) and 7K65-39 (500 Test Kit)Multiple Lot Numbers (see attached)ARTG Number: 180112
  • Manufacturer
    Abbott Australasia Pty Ltd Diagnostic Division

Manufacturer

Abbott Australasia Pty Ltd Diagnostic Division
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DHTGA