| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00190-1 |
| Product Name/Description |
Conceiveplease One Step HCG Urine Pregnancy test
(Included in ConceivePlease Kits)
Batch Number: 20131203
Expiry Date: 12 September 2016
ARTG Number: 212074 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall |
| Recall Action Instructions |
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. |
| Contact Information |
02 8999 8060 - Conceive Please
02 4655 8855 - Health Direction |