Events

Recall of VITEK® 2 Identification / Antimicrobial Susceptibility Test Cards

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by BioMerieux 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
    21681
  • Event Initiated Date
    2017-07-12
  • 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
    A potential issue was identified related to the white pouch which contains vitek® test cards. the manufacturer has determined that the integrity of some of the vitek® 2 test card pouches may be compromised. based on investigation, a compromised test card pouch can impact card reagents due to the entry of moisture.
  • Action
    Manufacturer to issue advice regarding use

Device

VITEK® 2 Identification / Antimicrobial Susceptibility Test Cards
  • Model / Serial
    Model: , Affected: VITEK 2 GN ID, VITEK 2 GP ID, VITEK 2 BCL ID, VITEK 2 NH ID, VITEK 2 ANC ID, VITEK 2 AST GP69, VITEK 2 AST P612, VITEK 2 AST ST01, VITEK 2 AST GN65, VITEK 2 AST N246, VITEK 2 AST GN82, VITEK 2 AST YS07, VITEK 2 AST N311, VITEK 2 AST GP76
  • Manufacturer
    BioMerieux Inc

Manufacturer

BioMerieux Inc