Events

Recall of Imagine Instant Pregnancy Test

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Point Of Care Diagnostics 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-2013-RN-00309-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00309-1
  • 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
    Point of care diagnostic has received a number of complaints of false positive and negative test results for the imagine instant pregnancy test.This recall action was carried out prior to approval of the recall strategy by the therapeutic goods administration.
  • Action
    Point of Care Diagnostics recovered remaining potentially affected stock from hospitals and retailers and replaced with an unaffected batch.

Device

Imagine Instant Pregnancy Test

Manufacturer

Point Of Care Diagnostics Australia Pty Ltd