Events

Recall of Biomerieux Vitek MS Instrument

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

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
    15506
  • Event Initiated Date
    2014-10-02
  • 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: BioMerieux New Zealand Ltd, Suite 4, The Business Connection Office, 2 Kalmia Street, Auckland 1544
  • Reason
    The vitek ms instrument is equipped with a transient recorder (tr) board associated with a specific firmware. this association is used to compute the time of flight of detected ions. some issues have been reported when firmware version 3.13 was installed on systems equipped with the old tr board (ref. 6200350). extensive testing has proven that firmware 3.13 may potentially cause an instrument to freeze or hang during acquisition when installed with the old tr board, with a risk of repeated results for different spots.
  • Action
    Software to be upgraded

Device

Biomerieux Vitek MS Instrument
  • Model / Serial
    Model: , Affected: All instruments with a Serial Number lower than #50039, Serial Number #50050, or Serial Number greater than #60000
  • Manufacturer
    Kratos Analytical Ltd

Manufacturer

Kratos Analytical Ltd