Events

Recall of VIDAS Anti HBs Total II. 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-2014-RN-01002-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-09-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01002-1
  • 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
    The information referenced in the current ifu is incorrect with regards to specimen stability for samples in stoppered tubes. in the instruction for use (ifu), the paragraph “specimen stability” states, “the stability of the sample separated from the clot has been validated using samples in stoppered tubes: at 18-25°c for 3 days”. further review identified that the data of the stability study mentioned in the product review development report file (ref. vr11) is “for stoppered tubes, at 18-25°c for 8 hours”. the instructions for use should state: “the stability of the sample separated from the clot has been validated using samples in stoppered tubes at 18-25°c for 8 hours”.
  • Action
    BioMerieux is notifying their customers that the IFU incorrectly states that sample is stable for 3 days at 18-25 degrees C once separated from the clot. The correct stability is 18-25 degrees C for 8 hours. This action has been closed-out on 01/03/2016.

Device

VIDAS Anti HBs Total II. An in vitro Diagnostic Medical Device (IVD)
  • Model / Serial
    VIDAS Anti HBs Total II. An in vitro Diagnostic Medical Device (IVD)Reference Number: 30318Lot Number: 1002903980
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd