Events

Retiro De Equipo (Recall) de COMMANDER SYSTEM -CORZYME-M (RDNA) EIA ASSAY

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
    24595
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2002-09-24
  • 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 has received reports of discoloured beads with light brown appearance in the product (should be white). probability of occurence is 1 in 1.4 million beads.

Device

COMMANDER SYSTEM -CORZYME-M (RDNA) EIA ASSAY
  • Modelo / Serial
    Model Catalog: 1236-25 (Lot serial: 85984M200.); Model Catalog: 1236 (Lot serial: 85984M200.); Model Catalog: 4A81-18 (Lot serial: 0.); Model Catalog: 4A81-18 (Lot serial: 88086HP00 85144HP00 83548HP0); Model Catalog: 7A92-36 (Lot serial: 88648M201 82180M101 82111M30); Model Catalog: 7A92-27 (Lot serial: 88648M201 82180M101 82111M30); Model Catalog: 7A92-26 (Lot serial: 88648M201 82180M101 82111M30); Model Catalog: 9006-24 (Lot serial: 1 83002M101.); Model Catalog: 9006-24 (Lot serial: 84767M301 86835M201 82300M20); Model Catalog: 9006-24 (Lot serial: M101 82843M101 85939M101); Model Catalog: 9006-24 (Lot serial: 1 86026M201 84768M301 84022); Model Catalog: 9006-24 (Lot serial: 86834M202 82841M101 88484M30); Model Catalog: 2A81 (Lot serial: M301.); Model Catalog: 2A81 (Lot serial: 1 84896M201 84283M201 85398); Model Catalog: 2A81 (Lot serial: 87026M401 88351M301 86279M20); Model Catalog: 2A81 (Lot serial: M301 87280M101 89525M200); Model Catalog: 2A81 (Lot serial: 1 86679M301 85021M401 88573); Model Catalog:
  • Descripción del producto
    CORZYME-M (RDNA)
  • 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