Events

Recall of NucliSENS Lysis Buffer. 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-00418-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-04-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00418-1
  • 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 coloured eluates, biomérieux's investigation confirmed an issue with a single lot of nuclisens lysis buffer. the eluate becomes coloured because of the presence of the heme group from the haemoglobin present in whole blood samples including dry blood spots. the root cause of the coloration is linked to the ph that, for the affected lot, has been observed to be 6.9 instead of 7.1 +/-0.1 as per product specification. the presence of haemoglobin causes the inhibition of the pcr. the result in most of the cases is uninterpretable test results as the internal control (ic) would also be inhibited, invalidating the test. in this case, there is a potential risk of delayed results. considering that the buffer is used in various protocols and downstream applications, and the worst case scenario in which the ic would not be inhibited, or not used although it is part of good laboratory practices, the tests run could potentially result in false negative results.
  • Action
    bioMérieux is advising users to stop using the affected lot of NucliSENs Lysis Buffer and to either quarantine or discard any stock of this lot. BioMerieux will arrange for pick up and credit, as required. Any concerns regarding previously reported results should be discussed with the Laboratory Medical Director to determine the appropriate course of action.

Device

NucliSENS Lysis Buffer. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    NucliSENS Lysis Buffer. An in vitro diagnostic medical device (IVD)Reference Number: 200292 Lot Number: 16092902 Expiry: 28 Aug 2018ARTG Number: 240760
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd