Events

Recall of Magnetic Silica MagSIL (used with NucliSENS easyMAG/eMAG nucleic acid extraction system for 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-01551-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-01-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01551-1
  • 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
    In july 2016 customers were informed about a decrease of extraction performances for some specific downstream applications with specific batches of magnetic silica (magsil). 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). the decrease of downstream application performances can lead to a risk of false negative, invalid or under-quantification results. if invalid results are obtained, it could lead to a delayed result until a new run or a new extraction is performed. since, biomérieux has identified subsequent batches that may be affected.
  • 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 is confirmed by the Laboratory Director, and to discuss any concerns regarding previously reported results with the Laboratory Director.

Device

Magnetic Silica MagSIL (used with NucliSENS easyMAG/eMAG nucleic acid extraction system for autom...
  • Model / Serial
    Magnetic Silica MagSIL (used with NucliSENS easyMAG/eMAG nucleic acid extraction system for automated extraction of total nucleic acids (RNA/DNA) from biological samples)An in vitro diagnostic medical device (IVD)Catalogue Number: 280133Lot Numbers: Z017KA1MS, Z017KB1MS (Expiry: 28/09/2017)Z017LE1MS (Expiry: 28/10/2017)Z017MA1MS (Expiry: 28/11/2017)Z017NA1MS, Z017NB1MS, Z017NC1MS, Z017ND1MS (Expiry: 28/12/2017)ARTG Number: 240760
  • Product Classification
    Hematology and Pathology Devices
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd