Events

Recall of ETEST® XM256 (Cefuroxime)

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Biomerieux SA.

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
    21145
  • Event Initiated Date
    2017-02-23
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Medi'Ray New Zealand Ltd, 53-55 Paul Matthews Road, Albany, Auckland 0632
  • Reason
    Investigation confirmed a potential performance issue on strain categorization for streptococcus pneumoniae and for enterobacteriaceae strains limited to oral cefuroxim breakpoints and based on 2016 clsi clinical standards only., for streptococcus pneumoniae on etest® xm256 (cefuroxime) foam and spb could lead to minor error on clinical strains:, o false susceptible result instead of intermediate results with bmd (broth micro dilution) reference method, o false intermediate result instead of resistant results with bmd reference method, for enterobacteriaceae on etest® xm256 (cefuroxime) foam and spb could lead to minor error on clinical strains:, o false susceptible result instead of intermediate results with ad (agar dilution) reference method, o false intermediate result instead of resistant results with ad reference method.
  • Action
    Manufacturer to issue advice regarding use

Device

ETEST® XM256 (Cefuroxime)
  • Model / Serial
    Model: , Affected: ETEST XM256 (Cefuroxime) WW SPB lot number1002884720, ETEST XM256 (Cefuroxime) WW SPB lot number 1003383650, ETEST XM256 (Cefuroxime) WW Foam lot number 1003075850, ETEST XM256 (Cefuroxime) WW Foam lot number 1003385930
  • Manufacturer
    Biomerieux SA

Manufacturer

Biomerieux SA