Recall of MICROSCAN RAPID NEG BREAKPOINT COMBO

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DADE BEHRING 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
    120214
  • Event Risk Class
    III
  • Event Initiated Date
    1999-08-06
  • Event Country
  • 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 error has been discovered in the dms version 22.00 or reater that affects the results for amicillin/k clavulante.

Device

  • Model / Serial
    Model Catalog: B1017-118 (Lot serial: 10MAR00 22FEB00 29DEC99)
  • Product Description
    MICROSCAN RAPID NEG BREAKPOINT COMBO
  • Manufacturer

Manufacturer

  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
  • Source
    HC