Events

Recall of PREPSTAIN - SLIDE PROCESSOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECTON DICKINSON CANADA INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    154040
  • Event Risk Class
    III
  • Event Initiated Date
    2011-06-24
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    The prepstaint instrument automatically prepares and stains slides for cytology. stains and rinses are applied to the sample in order to prepare the slide for cover slipping. a centrifuge is used as part of the sample preparation process. the centrifuge tube rack #2 is keyed incorrectly not allowing proper alignment of the tube holders with the prepstain waste station. this could result in potential delays in processing of slides and thus create potential delays in reporting of patient results.

Device

PREPSTAIN - SLIDE PROCESSOR
  • Model / Serial
    Model Catalog: 799-13001-02 (Lot serial: 236)
  • Product Description
    CENTRIFUGE TUBE RACKS FOR PRESTAIN
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.