Events

Recall of BioMerieux Vitek 2 System/ Vitek 2 Compact System

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by manufacturer #1479.

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
    14250
  • Event Initiated Date
    2013-02-22
  • 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
    Under specific conditions the vitek 2 and vitek 2 compact pc systems connected to a laboratory information system (lis) have the potertial to link a test result to an incorrect patient record., the four coditions required to potentially cause an occurence of this issue are:, patient demographics option is enabled, pateint demographics are not associated with the isolate, user does not resolve qualified isolates, laboratory re-uses lab ids (accession numbers) prior to qualified isolates being resolved.
  • Action
    Instructions for use to be updated

Device

BioMerieux Vitek 2 System/ Vitek 2 Compact System
  • Model / Serial
    Model: W0452,413642, 413862, W0449, W0447, W0441, W0438, 410615, 413861, 413411 and 27685., Affected:
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479