Events

Recall of ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - OXACILLIN

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BIOMERIEUX 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
    73372
  • Event Risk Class
    II
  • Event Initiated Date
    2017-04-03
  • 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 qc failures (mic out of range high) for s.Aureus atcc 29213 strain on etest ox 256 (oxacillin) foam packaging (ref. 520518) reported from the field biomerieux initiated a complaint investigation to confirm product issue and determine root cause. the investigation confirmed a potential performance issue for s. aureus atcc 29213 qc strain and clinical staphylococcus strains on etest? ox 256 (oxacillin) foam packaging (ref. 520518) whatever the media used when compared to the agar dilution reference method that could lead to false resistant results. the investigation states that etest? ox 256 (oxacillin) spb configuration (ref.412432) performs within the expected specifications. as a result of the referenced issue there is a potential performance issue on strain categorization for staphylococcus strains that could lead to major errors when compared to the ad (agar dilution) reference method (resistant result instead of susceptible result) when using 2017 clsi or 2017 eucast standards.

Device

ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - OXACILLIN
  • Model / Serial
    Model Catalog: 520518 (Lot serial: 1004319590); Model Catalog: 520518 (Lot serial: 1004070580); Model Catalog: 520518 (Lot serial: 1004818850); Model Catalog: 520518 (Lot serial: 1003055340); Model Catalog: 520518 (Lot serial: 1003315740)
  • Product Description
    ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - OXAC
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.