Events

Recall of MICROSCAN RAPID NEG ID PANEL

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
    68821
  • Event Risk Class
    III
  • Event Initiated Date
    2007-07-05
  • 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
    Potential to report incorrect antimicrobial interpretations for extended-spectrum beta-lactamase (esbl)-producing organisms when the group level id feature for processing fluorogenic gram neg panels is enabled.

Device

MICROSCAN RAPID NEG ID PANEL
  • Model / Serial
    Model Catalog: B1017-110 (Lot serial: FLUOROGENIC GRAM NEGATIVE); Model Catalog: B1017-110 (Lot serial: PANEL WILL BE AFFECTED.); Model Catalog: B1017-110 (Lot serial: ONLY CUSTOMERS USING)
  • Product Description
    RAPID GRAM NEG ID 3 PANEL (RNID3)
  • Manufacturer
    DADE BEHRING CANADA INC.

Manufacturer

DADE BEHRING CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC