ConceivePlus, in consultation with the TGA, has recalled a batch of ConceivePlease one-step human chorionic gonadotropin urine pregnancy tests.
The affected batch number is 20131203. ConceivePlease one step HCG urine pregnancy tests are supplied in ConceivePlease Kits.
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.
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.
Fewer than 100 kits from the affected batch were supplied to retailers during a three week period, from 21 January to 11 February 2016.
Consumers who suspect they may have used a ConceivePlease one step hCG pregnancy test from the affected batch are being encouraged to retest with a different product or with another ConceivePlease one step hCG urine pregnancy test from an unaffected batch, and to talk with their health professional about any concerns.