Events

Retiro De Equipo (Recall) de ARCHITECT 25-OH VITAMIN D - REAGENT

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
    90058
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2011-02-15
  • 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
    Customer complaints have been received for an error in the maximum on-board stability time displayed on the architect when using lot 01110l000. upon loading a new kit of lot 01110l000 onto the architect and scanning the barcode the kit displays an incorrect on board stability of 1680 hours which would equal 70 days. the correct on board stability time is 168 hours which would equal 7 days. the reagent package insert (commodity 49-2152/r1) states in the storage instructions section "the architect 25-oh vitamin d 100-test reagent kit may be stored on board the architect i system for a maximum of 7 days." the conversion of 7 days into hours is 168 hours.

Device

ARCHITECT 25-OH VITAMIN D - REAGENT

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