| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00244-1 |
| Product Name/Description |
Mums The One One Step hCG Urine Pregnancy Test
Batch Number: 20151106
ARTG Number: 152301 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/03/2016 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall |
| Recall Action Instructions |
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. |
| Contact Information |
02 6299 1996 - Mums The One |