Events

Recall of Mums The One One Step hCG Urine Pregnancy Test

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Mums The One.

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-00244-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00244-1
  • 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
    Testing undertaken by the tga for the above batch of 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 10miu/ml or 25mlu/ml can be detected".Batch 20151106 failed to detect hcg in human urine at concentrations of 10miu/ml, and 25miu/ml and 50miu/ml levels.False negative results in the worst case can result in misdiagnosis, which can have significant consequences.
  • Action
    Customers are advised to quarantine any unused stock from the affected batch and contact Mums The One to arrange for the return of the affected stock and a refund. If you suspect that you may have used a Mums The One one step hCG pregnancy test from the affected batch, it is recommended that you retest with a different product.

Device

Mums The One One Step hCG Urine Pregnancy Test
  • Model / Serial
    Mums The One One Step hCG Urine Pregnancy TestBatch Number: 20151106 ARTG Number: 152301
  • Manufacturer
    Mums The One

Manufacturer

Mums The One
  • Source
    DHTGA