Events

Recall of VITEK 2 Gram Positive- ID Card

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
    22243
  • Event Initiated Date
    2017-11-10
  • 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
    An internal investigation has confirmed, occurrences of atypical negative o129r reactions for enterococcus casseliflavus atcc® 700327™ in association with three(3) vitek® 2 gp id, causing failure of the quality control (qc) testing for the vitek® 2 gp id card. in accordance with the vitek® 2 gp id instructions for use, the expected o129r reaction for atcc® 700327™ strain is positive. as a precaution, the manufacturer is also including in the scope of this notice all gp id card lots manufactured with the same raw materials.
  • Action
    Product to be destroyed

Device

VITEK 2 Gram Positive- ID Card
  • Model / Serial
    Model: , Affected: VITEK® 2 GP ID Lots #2420192403, 2420198203
  • Manufacturer
    Biomerieux SA

Manufacturer

Biomerieux SA