Events

Recall of VITEK 2 Gram-Positive (GP) Identification (ID) Test Kit. An in vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Biomerieux Australia Pty 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
    RC-2017-RN-01333-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01333-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Biomérieux have received customer reports indicating occurrences of atypical negative o129r reactions for enterococcus casseliflavus atcc 700327 in association with specific vitek 2 gp id lots, causing failure of the quality control (qc) testing for the vitek 2 gp id card. the expected o129r reaction for atcc 700327 strain is positive.An internal investigation determined that a positive dsor reaction that occurs early in the incubation of the card is causing an earlier end to the analysis of the card leading to an atypical negative reaction for o129r.
  • Action
    bioMérieux is advising users to review inventory and discard any remaining stocks of the affected lots. A review of previously generated results is at the discretion of the Laboratory Manager.

Device

VITEK 2 Gram-Positive (GP) Identification (ID) Test Kit. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    VITEK 2 Gram-Positive (GP) Identification (ID) Test Kit. An in vitro diagnostic medical device (IVD)Batch/Lot Number: 2420192403Expiry: 06 June 2018Batch/Lot Number: 2420198203Expiry: 12 June 2018ARTG Number: 215320
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd