Events

Recall of Biomerieux Etest Ertapenem foam and Single Blister Packs

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
    16265
  • Event Initiated Date
    2014-02-20
  • 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
    Biomérieux has identified that the affected etest strips do not give the correct minimum inhibitory concentration (mic) for some quality control strains, with the mic results out of range (high) according to the mic specification described in the quality control procedure., the mic results conformed at the time of batch release however investigations have confirmed this issue appears over time, leading to a performance issue by overestimating the mic.
  • Action
    Product to be destroyed

Device

Biomerieux Etest Ertapenem foam and Single Blister Packs
  • Model / Serial
    Model: Reference Numbers: 531618, 531640, 415332, Affected: Lots: 1002054430, 1000853690 & 1001960650, 1002110560 & 1002389880
  • Manufacturer
    Biomerieux SA

Manufacturer

Biomerieux SA