Events

Recall of First Response Digital Pregnancy Test and First Response Test & Reassure. 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 Church and Dwight 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-2017-RN-00212-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-02-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00212-1
  • 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
    It has been determined that during consumer use, the internal mechanism of the affected devices is giving an error reading which is shown as "?" on the display. there are no health risks associated with this issue; the device will not give a false positive or false negative result reading.
  • Action
    Church & Dwight is advising wholesalers to inspect their stock and quarantine affected stock to prevent further sale. Affected stock is to be returned to Cargo Line International. Wholesalers are requested to provide a copy of the recall letter to other warehouses, retail facilities or other organisations to which they have transferred or supplied affected product. Consumers will be provided a full refund, from where they purchased the product or by contacting Church & Dwight Customer Service, for devices from the affected batches that have resulted in an invalid (“?”) reading. This action has been closed-out on 23/06/2017.

Device

First Response Digital Pregnancy Test and First Response Test & Reassure. An in vitro diagnostic ...
  • Model / Serial
    First Response Digital Pregnancy Test and First Response Test & Reassure. An in vitro diagnostic medical device (IVD).First Response Digital Pregnancy Test Product Code: 0734Lot Numbers: SU5341 (exp 07/2017), SU6207, SU6237, SU6305A (exp 07/2017), SU6308 (exp 10/2017), SU6335 (exp 10/2017)First Response Test & ReassureProduct Code: 0737Lot Numbers: SU6196 (exp 07/2017), SU6315A (exp 10/2017)ARTG Number: 231933
  • Manufacturer
    Church and Dwight Australia Pty Ltd

Manufacturer

Church and Dwight Australia Pty Ltd