Events

Recall of VITEK 2 60/XL and VITEK 2 Compact systems (In vitro diagnostic medical devices (IVD) used Bacterial identification and antibiotic sensitivity system)

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-2013-RN-00168-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-02-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00168-1
  • 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
    Under specific conditions, vitek 2 60/xl and vitek 2 compact pc systems connected to a laboratory information system have the potential to link a test result to an incorrect patient record. the four conditions required to potentially cause an occurrence of this issue are:- patient demographics option is enabled- patient 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
    Biomerieux is updating the instructions for use (IFU), addendum to the software user manual, to include appropriate instructions for resolution of Qualified isolates as a short term action. Biomerieux is implementing a software solution to reduce the likelihood of occurrence of this issue in the next software update, version 7.01 targeted for launch in November 2013.

Device

VITEK 2 60/XL and VITEK 2 Compact systems (In vitro diagnostic medical devices (IVD) used Bacteri...
  • Model / Serial
    VITEK 2 60/XL and VITEK 2 Compact systems (In vitro diagnostic medical devices (IVD) used Bacterial identification and antibiotic sensitivity system) Used with the following PC models:Hewlett-Packard rp5700, Catalogue Number W0452Hewlett-Packard rp5800 XPE, Catalogue Number 413642Hewlett-Packard WES7, Catalogue Number 413862Hewlett-Packard dc7800, Catalogue Number W0449Hewlett-Packard dc7700 8-port, Catalogue Number W0447Hewlett-Packard dc7100 8-port, Catalogue Number W0441
  • Product Classification
    Immunology and Microbiology Devices
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd