Events

Recall of BD MAX MRSA ASSAY

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
    151052
  • Event Risk Class
    III
  • Event Initiated Date
    2014-07-22
  • 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
    Based on investigation of incorrect results related to the college of american pathologists (cap) surveys mrs5-a 2014 and mrs5-b 2014 using the bd-max mrsa assay it was confirmed that one of the samples for each of the surveys yielded some false positive results. while there is the potential for false positive result for specimens from patients who are positive for certain strains of methicillin-sensitive staphylococcus aureus (mssa) when present at high loads bd believes that such an occurence is unlikely and overall clinical performance would not be affected.

Device

BD MAX MRSA ASSAY
  • Model / Serial
    Model Catalog: 442953 (Lot serial: >10 numbers contact mfg)
  • Product Description
    BD MAX MRSA ASSAY
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.