Events

Retiro De Equipo (Recall) de VITEK 2 COMPACT 30 SYSTEM - SUSCEPTIBILITY TEST CARDS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BIOMERIEUX CANADA INC..

¿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
    28513
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-04-21
  • 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
    A vitek 2 card pouch integrity issue has been identified for a portion of the card pouches manufactured with raw material white webbing. reports from customers have indicated occurrences of higher-than-expected mic results for imipenem and nitrofurantoin. multiple card types/lots are referenced in the complaints. one of the customers determined via parallel testing that cards contained in white pouches showing visual evidence of a puncture or tear in the pouch at the stitch seal sometimes provided higher mic values than pouches with no evidence of flaw. an investigation was conducted to determine the root cause and scope of the pouch integrity issue. the investigation confirmed that a card pouch defect can allow humidity/moisture to impact the card. moisture sensitivity can lead to antibiotic degradation (loss of potency). this could explain the increased antibiotic resistance experienced by some customers. the investigation determined the root cause was combinations of stitch seal wheel design/positioning on the manufacturing equipment and product shipping/handling. the investigation concluded the card pouch integrity issue potentially impacts 204 card types (504 lots) worldwide.

Device

VITEK 2 COMPACT 30 SYSTEM - SUSCEPTIBILITY TEST CARDS
  • Modelo / Serial
    Model Catalog: 413 066 (Lot serial: More than 10 contact manuf.); Model Catalog: 413 063 (Lot serial: More than 10 contact manuf.); Model Catalog: 413 062 (Lot serial: More than 10 contact manuf.); Model Catalog: 412 864 (Lot serial: More than 10 contact manuf.); Model Catalog: 410 028 (Lot serial: More than 10 contact manuf.); Model Catalog: 22233 (Lot serial: More than 10 contact manuf.); Model Catalog: 22226 (Lot serial: More than 10 contact manuf.); Model Catalog: 413402 (Lot serial: 5910280203); Model Catalog: 413404 (Lot serial: 5930287103); Model Catalog: 413404 (Lot serial: 5930279103); Model Catalog: 420 580 (Lot serial: More than 10 contact manuf.); Model Catalog: 415 670 (Lot serial: More than 10 contact manuf.); Model Catalog: 414 971 (Lot serial: More than 10 contact manuf.); Model Catalog: 414 967 (Lot serial: More than 10 contact manuf.); Model Catalog: 413 083 (Lot serial: More than 10 contact manuf.); Model Catalog: 413230 (Lot serial: 1480248203); Model Catalog: 413230 (Lot serial: 14802432
  • Descripción del producto
    VITEK 2 COMPACT 30 SYSTEM - SUSCEPTIBILITY TEST C;VITEK 2 AST GN71;VITEK 2 AST GN73;VITEK 2 AST XN05;VITEK 2 AST GN67;VITEK 2 AST GN70;VITEK 2 ANC ID;VITEK 2 AST GN48;VITEK 2 AST XN06;VITEK 2 AST N298;VITEK 2 AST GP76;VITEK 2 AST GN86;VITEK 2 AST N223;VIT
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.