| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00212-1 |
| Product Name/Description |
First Response Digital Pregnancy Test and First Response Test & Reassure. An in vitro diagnostic medical device (IVD).
First Response Digital Pregnancy Test
Product Code: 0734
Lot Numbers: SU5341 (exp 07/2017), SU6207, SU6237, SU6305A (exp 07/2017), SU6308 (exp 10/2017), SU6335 (exp 10/2017)
First Response Test & Reassure
Product Code: 0737
Lot Numbers: SU6196 (exp 07/2017), SU6315A (exp 10/2017)
ARTG Number: 231933 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
21/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall |
| Recall Action Instructions |
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. |
| Contact Information |
1800 222 099 - Church & Dwight Australia Customer Service |