Retiro De Equipo (Recall) de i-STAT PT/INR Cartridges(prothrombin time test)

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 Point-of-Care 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 point of care inc. (apoc) has determined that certain lots of i-stat pt/inr cartridges may generate a higher than typical number of pt/inr star outs, due to the internal quality system suppressing results if the analyser or cartridge does not meet certain internal specifications. there is a potential to delay the generation of patient results for pt/inr due to the star outs. when results are generated they are within the expected performance of the assay.
  • Acción
    Cartridges can continue to be used for patient testing. If you repeatedly observe the condition where cartridges from the lots listed above display star outs, please contact Abbott Customer Support for your country and they will organise replacement of impacted stock. This action has been closed-out on 02/05/2017.


  • Modelo / Serial
    i-STAT PT/INR Cartridges(prothrombin time test)List Number: 03P89-24Lot Number: All lots from S15007 to S15026 inclusive and All lots from T15037A to T15076A inclusiveARTG Number: 213851
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • 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