Events

Recall of NucliSENS easyMAG Magnetic Silica MagSIL (used with the NucliSENS easyMag nucleic acid extraction system for the automated extraction of total nucleic acids (RNA/DNA) from biological 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-00949-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-07-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00949-1
  • 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 customer complaints about amplification performance issues with home brew pcr and rt- pcr assays, biomérieux investigation has confirmed an issue with specific batches of magnetic silica (ref: 280133). the investigation concluded that downstream applications were impacted when the extraction volume was higher than 400µl and for double stranded nucleic acids target. double stranded nucleic acid applications with small (< 40kbp) and medium genome sizes (< to 1200 kbp) i.E., dna viruses are more impacted than higher human genomic dna and bacterial applications (> to 1200kbp).This may result in false negative, invalid or under-quantification of results. if invalid results are obtained, it could lead to a delayed result until a new run or a new extraction is performed.
  • Action
    bioMérieux is advising users to ensure controls with the same nature/structure as the target and/or external controls are used to detect the issue. Users are advised to reduce the sample input volume to 200µL, until the silica problems is resolved. Downstream ARGENE and NucliSENS easyQ HIV 1 V2.0 applications performed according to the IFU are not affected. It is recommended that the continued use with blood transfusion testing with confirmed by the Laboratory Director, and to discuss any concerns regarding previously reported results with the Laboratory Director.

Device

NucliSENS easyMAG Magnetic Silica MagSIL (used with the NucliSENS easyMag nucleic acid extraction...
  • Model / Serial
    NucliSENS easyMAG Magnetic Silica MagSIL (used with the NucliSENS easyMag nucleic acid extraction system for the automated extraction of total nucleic acids (RNA/DNA) from biological samples). An in vitro diagnostic medical device (IVD)Catalogue Number: 280133Lot Numbers:Z017BB1MS, Z017BF1MS, Z017BA1MS Expiry Date: 28/02/2017Z017CC1MS, Z017CG1MS Expiry Date: 28/03/2017Z017DC1MS, Z017DD1MSExpiry Date: 28/04/2017ARTG Number: 240760
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd