Events

Recall of Conceiveplease One Step HCG Urine Pregnancy test(Included in ConceivePlease Kits)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Conceiveplease 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-00190-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-02-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00190-1
  • 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 testing undertaken by the tga for the above batch of conceiveplease one step hcg urine pregnancy test has shown that this batch does not comply with the claim in the instructions for use which specify that "ln less than 5 minutes, levels of hcg as low as 25mlu/ml can be detected".Batch 20131203 failed to detect hcg in human urine at concentrations of 10 and 25miu/ml levels. false negative results in the worst case can result in misdiagnosis, which can have significant consequences. the tga is undertaking further investigations to ascertain if any further actions are required.
  • Action
    Please note that ConceivePlease Pty Ltd has advised the TGA that only fewer than 100 kits from the affected batch were supplied to retailers during a three week period, from 21 January to 11 February 2016. Customers are advised to quarantine any unused stock from the affected batch and return them to the place of purchase for a refund. For more information please see http://www.tga.gov.au/alert/conceiveplease-one-step-hcg-urine-pregnancy-test . This action has been closed-out on 19/01/2017.

Device

Conceiveplease One Step HCG Urine Pregnancy test(Included in ConceivePlease Kits)
  • Model / Serial
    Conceiveplease One Step HCG Urine Pregnancy test(Included in ConceivePlease Kits)Batch Number: 20131203Expiry Date: 12 September 2016ARTG Number: 212074
  • Manufacturer
    Conceiveplease Pty Ltd

Manufacturer

Conceiveplease Pty Ltd
  • Source
    DHTGA