Events

Retiro De Equipo (Recall) de 5 ML REACTION VESSELS

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
    56697
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-07-09
  • 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
    During run setup on an m2000sp instrument a customer found two 5 ml reaction vessels list number 04j71-20 with missing rims that fell through the 1ml subsystem carrier. some of the 5 ml reaction vessels(rvs) in the affected lots may have an insufficient rim. an rv with an insufficient rim may not be held securely in the 1ml subsystem carrier. this may cause the rv to be seated incorrectly in the carrier or drop through it.

Device

5 ML REACTION VESSELS
  • Modelo / Serial
    Model Catalog: 04J71-20 (Lot serial: 56944001); Model Catalog: 04J71-20 (Lot serial: 57026001); Model Catalog: 04J71-20 (Lot serial: 57059001); Model Catalog: 04J71-20 (Lot serial: 57673001)
  • Descripción del producto
    5 ML REACTION VESSELS USED WITH THE M2000SP INSTRUMENT
  • 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