Events

Recall of PregSure Digital Pregnancy Test & Pregsure Pregnancy Test. 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 Genesis Biotech 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-00230-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00230-1
  • 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
    Genesis biotech pty ltd has been advised that testing by thetga has identified that two batches of pregsure digital pregnancy test strips and pregsure pregnancy test strips were not sensitive to hcg at 25 miu/ml. consequently, these batches are being recalled.
  • Action
    Pharmacies are to inspect stocks and quarantine all units from the affected batches. Genesis Biotech will arrange for the quarantined stock to be recovered and replacement stock or a credit note to be issued.

Device

PregSure Digital Pregnancy Test & Pregsure Pregnancy Test. An in vitro diagnostic medical device ...
  • Model / Serial
    PregSure Digital Pregnancy Test & Pregsure Pregnancy Test. An in vitro diagnostic medical device (IVD).PregSure Digital Pregnancy TestCatalogue Number: LS-620Batch Number: 16D119-1100PregSure Pregnancy Test (midstream)Catalogue Number: LS-633Batch Number: 16D119-0000ARTG Number: 236402
  • Manufacturer
    Genesis Biotech Pty Ltd

Manufacturer

Genesis Biotech Pty Ltd