Events

Retiro De Equipo (Recall) de Architect Sex Hormone Binding Globulin (SHBG) reagents. 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 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-00519-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-04-26
  • 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-00519-1
  • 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 has identified that architect shbg results generated with the potassium edta specimen tube type may demonstrate a negative shift relative to results generated with serum. shbg dimer destabilisation in edta could result in low shbg measurements by immunoassay. in other words, there is a potential for falsely decreased architect shbg results to be generated when using the architect shbg assay with the potassium edta specimen tube type. internal studies have determined the use of the potassium edta specimen tube type may result in a decrease in shbg concentration values of greater than 20% when compared with serum collected in serum tubes. the shift was observed across the full analytical range of the assay. as a result, an increase in free androgen index / free testosterone index calculations of up to 30% may also be observed when using potassium edta specimen tubes.
  • Acción
    Abbott Diagnostics is advising users to immediately discontinue the use of the Potassium EDTA specimen tube type with the ARCHITECT SHBG assay. Users are requested to review the recall notification with their Medical Director to ensure that they are aware of this issue and to determine if a review of previously generated results using the Potassium EDTA specimen tube type is required.

Device

Architect Sex Hormone Binding Globulin (SHBG) reagents. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Architect Sex Hormone Binding Globulin (SHBG) reagents. An in vitro diagnostic medical device (IVD)List Number: 8K26-20Lot Numbers: 01916E000, 00316F000, 01816G000, 00916I000, 07316I000 and 00916L000List Number: 8K26-25Lot Numbers: 01816E000, 00216F000, 01716G000, 00816I000 and 07216I000ARTG Number: 196075
  • 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