Events

Recall of Merifluor EBV VCA IgM IFA (an Immunofluorescence Test for the Detection of Antibodies). 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 Bioline Aust 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-00167-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-02-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00167-1
  • 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
    A report has been received that the foil pouches for some ebv-na substrate slides appear to have been damaged, resulting in exposure to moisture and a decrease in slide reactivity/loss of fluorescence. it has also been determined that the desiccant packaged with the compromised ebv-na substrate slides have turned pink, indicating exposure to moisture. the desiccants are typically blue. internal testing has demonstrated that the positive control tested with an ebv-na substrate slide from a damaged pouch with pink desiccant shows no fluorescence, which is interpreted as an invalid reaction according to the product package insert. there is no impact to patients. this action was carried out prior to consultation with the therapeutic goods administration (tga).
  • Action
    Bioline is advising users to check the colour of the desiccant prior to use. If the desiccant is pink, the slides should not be used. Blue desiccant pouches can be used to testing if the control results are acceptable. This action has been closed-out on 03/08/2016.

Device

Merifluor EBV VCA IgM IFA (an Immunofluorescence Test for the Detection of Antibodies). An in vit...
  • Model / Serial
    Merifluor EBV VCA IgM IFA (an Immunofluorescence Test for the Detection of Antibodies). An in vitro diagnostic medical device (IVD)Lot Number: EB150G160Substrate Slide Lot Number: 2921-366Expiry Date: 30 June 2016ARTG Number: 214645
  • Manufacturer
    Bioline Aust Pty Ltd

Manufacturer

Bioline Aust Pty Ltd