Events

Recall of BK Virus R-gene Real-time Detection and Quantification Kit (used to measure the viral load of BK virus in whole blood, plasma and urine samples). 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-2016-RN-01041-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01041-1
  • 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
    Following a customer complaint about difficulties to interpret low viral load in whole blood samples, a biomérieux investigation showed that the sensitivity of the bk virus r-gene of 260 copies/ml (corresponding to 2.41 log10) claimed in the ifu for whole blood was not confirmed. a limit of detection (lod) experiment conducted with whole blood samples has led to a lod value of 1578 copies/ml (corresponding to 3.20 log10).The issue only impacts whole blood samples with a low viral load (260 to 1578 copies/ml), where amplification leads to creeping/flat amplification curves that are difficult to interpret. these problems of interpretation could lead to:- a false negative result,- a delayed result until a new run or a new test is performed.This issue has no impact on negative results or on high positive samples, as the amplification curves are well identified and also, does not impact the test when urine or plasma samples are used.
  • Action
    bioMérieux is advising users that the Limit of Detection (LOD) is 1578 copies/mL rather than 260 copies/mL for whole blood samples until the root cause is identified and corrected. In addition, bioMérieux is advising that in case of doubt or for attended low viral load samples, testing should be performed on plasma or urine samples instead whole blood samples. Any concerns regarding previously reported results should be discussed with the Laboratory/Medical Director to determine the appropriate course of action. Following the completion of the manufacturer’s investigation, further actions may be undertaken.

Device

BK Virus R-gene Real-time Detection and Quantification Kit (used to measure the viral load of BK ...
  • Model / Serial
    BK Virus R-gene Real-time Detection and Quantification Kit (used to measure the viral load of BK virus in whole blood, plasma and urine samples). An in vitro diagnostic medical device (IVD).Catalogue Number: 69-013BLot Numbers:1003909940, expiry 12-03-20171004754140, expiry 04-02-20181004764070, expiry 04-02-2018ARTG Number: 211361
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd