Events

Retiro De Equipo (Recall) de BBL MGIT MYCROBACTERIA GROWTH INDICATOR TUBE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BECTON DICKINSON 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
    26656
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-09-16
  • 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
    Product contained incorrect barcodes where the labels began with "43 02" rather than the required "43 01". these batches were placed on quality notification and dispositioned for rework to over-label the barcode area with the correct symbology. the over-label was manually applied to each tube. one customer complaint was received where the over-label had partially peeled off of the tube the incorrect barcode underneath was scanned into the mgit instrument and the epicenter connected to the customer's laboratory system incurred an error. the customer also noted that they found additional tubes in their shipment that had multiple labels or no over-label. the label prefix specifically the 3rd and 4th digits that indicate the media type gives the instrument information for what algorithm to apply for growth detection. growth detection testing will be performed by the mgit instrument every 60 minutes as usual on tubes containing incorrect barcode prefixes but will not flag as positive when growth is visible because media type "43 02" is not defined. a barcode overlabel peeling off exposing an incorrect barcode causes mgit false negative results by not flagging positive tubes. susceptibility tests are not affected since susceptibility testing is conducted in a carrier where instrument instruction is provided by the carrier.

Device

BBL MGIT MYCROBACTERIA GROWTH INDICATOR TUBE
  • Modelo / Serial
    Model Catalog: 245122 (Lot serial: 3053240); Model Catalog: 245122 (Lot serial: 3061013)
  • Descripción del producto
    BBL MGIT Mycobacteria Growth Indicator Tube
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.