PRA number
2016/15224
Published date
Product description
ConceivePlease One Step HCG Urine Pregnancy test (Included in ConceivePlease Kits)
Reasons the product is recalled
TGA testing of ConceivePlease one step hCG urine pregnancy test kits from the affected batch found that these kits do not meet a claim made in the product documentation. Specifically, these tests failed to detect hCG at concentrations of 25 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 ConceivePlease 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 20131203, return them to the place of purchase for a refund.
If you suspect that you may have used a ConceivePlease one step hCG pregnancy test from the affected batch, it is recommended that you retest with a different product or with another ConceivePlease one step hCG urine pregnancy test from an unaffected batch.
If you have any questions or concerns about this issue, speak to your health professional.
If any are from batch number 20131203, return them to the place of purchase for a refund.
If you suspect that you may have used a ConceivePlease one step hCG pregnancy test from the affected batch, it is recommended that you retest with a different product or with another ConceivePlease one step hCG urine pregnancy test from an unaffected batch.
If you have any questions or concerns about this issue, speak to your health professional.
Supplier
ConceivePlease Pty Ltd
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.