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
    56247
  • Event Risk Class
    II
  • Event Initiated Date
    2012-09-04
  • 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
    A software issue which may affect bd prepstain slide processors running one of the following software versions: - gyn 1.2 and non-gyn 2.80 - gyn 1.3.0.1 and non-gyn 2.80 rack layout data for software version non-gyn 2.80 are incorrectly reset when gyn software version gyn 1.2 or 1.3.0.1 are subsequently installed on the system. this will result in a loss of chain of custody for non-gynecological samples. when the issue occurs the first 12 samples are not processed at all and all others (up to 36 per run) are deposited on the wrong slide. the risk is highest for customers who have software version gyn 1.3.0.1 (released in june 2008). it is also possible that the issue could occur with software version gyn 1.2 (released in october 2005). there is no impact to gynecological specimen processing (pap tests). in september 2008 all customers using the bd prepstain slide processor were made aware of this software issue and informed that the error may have potentially resulted in mismatched patient results. a process was initiated and is still ongoing to upgrade software for affected customers. bd-canada field service personnel will be upgrading (or have already upgraded) all bd prepstain slide processors to unaffected software versions (gyn 1.3.0.2 or gyn 1.3.0.3).

Device

PREPSTAIN - SLIDE PROCESSOR
  • Model / Serial
    Model Catalog: 799-13000-00 (Lot serial: All); Model Catalog: 799-14000-00 (Lot serial: All); Model Catalog: 490407 (Lot serial: All)
  • Product Description
    BD PrepStain Slide Processor
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.