ConceivePlease Pty Ltd—ConceivePlease One Step HCG Urine Pregnancy test

PRA number

2016/15224

Published date

Product description

ConceivePlease One Step HCG Urine Pregnancy test (Included in ConceivePlease Kits)
Identifying features
The affected batch number is 20131203.

Other identifying numbers

The affected batch number is 20131203.

What are the defects?

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.

What are the hazards?

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 should consumers 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.

Supplier

ConceivePlease Pty Ltd

Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

Product category