PRA number
2016/15255
Published date
Product description
Mums The One One Step hCG Urine Pregnancy Test
Reasons the product is recalled
TGA testing of Mums The One one step hCG urine pregnancy tests from the affected batch found that these tests do not meet a claim made in the product documentation. Specifically, these tests failed to detect hCG at concentrations of 10 mIU/mL, 25 mIU/mL and 50 mIU/mL levels.
The hazards to consumers
This creates the risk of false negative results, which means a pregnant woman may not seek pre-natal healthcare advice and support as early as possible, and may continue with behaviours that could affect foetal development, such as smoking and/or consuming alcohol.
What consumers should do
If you have any unused Mums The One one step hCG urine pregnancy tests, check the batch number shown on the packaging to see if it is from the affected batch.
If any are from batch number 20151106, contact PregnancyShop.com.au for a refund.
If you have recently used a pregnancy test and are unsure if it came from the affected batch, check with the place of purchase.
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.
If you have any questions or concerns about this issue, speak to your health professional.
If any are from batch number 20151106, contact PregnancyShop.com.au for a refund.
If you have recently used a pregnancy test and are unsure if it came from the affected batch, check with the place of purchase.
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.
If you have any questions or concerns about this issue, speak to your health professional.
Supplier
Mums The One T/A PregnancyShop.com.au
Traders who sold this product
PregnancyShop.com.au
Where the product was sold
Nationally
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.