TGA issues recall for faulty pregnancy tests

The TGA and ConceivePlease have recalled a batch of urine pregnancy tests because of a risk of false negatives.

The affected product is the one-step human chorionic gonadotropin (hCG) test supplied in ConceivePlease kits. The batch number is 20131203.

TGA tests have found that kits from the affected batch do not meet a claim in the product documentation that they can 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,