Events

Retiro De Equipo (Recall) de I-STAT KAOLIN ACT CARTRIDGE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ABBOTT LABORATORIES LIMITED. 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
    61402
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-02-23
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Abbott point of care inc. (apoc) has determined that celite act and kaolin act cartridges may produce falsely low results when very high clotting time samples are tested. patient samples with a measured clot time of >853 seconds for celite and >1134 seconds for kaolin may display results of approximately 100 to 200 seconds while using jams142e. the typical therapeutic range of the i-stat act assay is 200 to 600 seconds.

Device

I-STAT KAOLIN ACT CARTRIDGE
  • Modelo / Serial
    Model Catalog: (Lot serial: JAMS142E); Model Catalog: 03P75-06 (Lot serial: JAMS142E); Model Catalog: 04P75-01 (Lot serial: JAMS142E); Model Catalog: 06F16-10 (Lot serial: JAMS142E)
  • Descripción del producto
    I-STAT KAOLIN ACT CARTRIDGES;I-STAT CELITE ACT CARTRIDGES;I-STAT 1 ANALYZER SOFTWARE
  • Manufacturer
    ABBOTT LABORATORIES LIMITED. DIAGNOSTIC DIVISION

Manufacturer

ABBOTT LABORATORIES LIMITED. DIAGNOSTIC DIVISION
  • Dirección del fabricante
    MISSISSAUGA
  • 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
    HC