Events

Recall of BK Virus R-gene Real-time Detection and Quantification 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-00806-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-06-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00806-1
  • 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 has observed significant differences between the fit point and 2nd derivative analysis methods on lightcycler amplification platforms for low positive whole blood samples.Investigation showed that the significant differences (>0,5 log10 cp/ml) have been obtained for bk virus low viral loads (inferior to around 25 000 cp/ml - corresponding to around 4.40 log10 cp/ml - determined by fit point) on whole blood samples with the bk virus r-gene assay. these differences between the two methods are due to the shape of the curves for low positive whole blood samples.
  • Action
    Users are requested to take the following actions at this time: ? Please distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred our product. ? Stop using the 2nd derivative method for whole blood samples on LightCycler 1.0, 2.0 and 480 until the improved BK Virus R-gene kit was released. Use the Fit Point method with these LightCyclers. ? Contact your local customer service if you observe the issue.

Device

BK Virus R-gene Real-time Detection and Quantification Kit. An in vitro diagnostic medical device...
  • Model / Serial
    BK Virus R-gene Real-time Detection and Quantification Kit. An in vitro diagnostic medical device (IVD)Reference Number: 69-013BPack Size: 90 testsIFU Version: 21258D Lot Numbers: 1004754140 and 1004764070 Expiration Date: 4 Feb 2018IFU Version: 21258E (new version) Lot Numbers: 1004965280Expiration Date: 22 Nov 2018ARTG Number: 211361
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd