Events

Recall of VITEK 2 system version 7.01. 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-2015-RN-00132-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-02-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00132-1
  • 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
    Vitek 2 software ver. 7.01 introduced a feature (enable > convention for highest reportable mic) which can be used to modify the ast (antimicrobial susceptibility testing) reporting convention when an ast result is within the highest reportable mic range. advanced expert system (aes) parameter sets are configurable in the vitek 2 software to allow users to select mic breakpoint interpretation.The enable > convention for highest reportable minimum inhibitory concentration (mic) configuration option modifies the highest reportable mic value for each specific antimicrobial to half its doubling dilution and displays the value with a > (greater than) symbol. for example, =32 (highest reportable mic) would be modified to >16 which are equivalent for mic testing.Patient isolates function as intended; however, the software does not recognise the two values (e.G. =32 vs. >16) as equivalent, and incorrectly flags the modified value as a deviation.
  • Action
    Biomeriux is requesting their customers that in the event of a QC deviation for one or more of the ATCC strains and antibiotics indicated, to compare the reported MIC value to the expected MIC value. If the values are equivalent, the deviation is subject to the software discrepancy and can be ignored. This issue will be corrected in software release 8.01 This action has been closed-out on 09/08/2016.

Device

VITEK 2 system version 7.01. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    VITEK 2 system version 7.01. An in vitro diagnostic medical device (IVD)Catalogue number: 416381ARTG: Transitioning
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd