ConceivePlease one step hCG urine pregnancy test

Related information

Recall – potential decreased sensitivity and risk of false negative results

26 February 2016

Consumers and health professionals are advised that ConceivePlease, in consultation with the TGA, is recalling one batch of ConceivePlease one step human chorionic gonadotropin (hCG) urine pregnancy tests. The affected batch number is 20131203.

ConceivePlease one step hCG urine pregnancy test

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.

Information for consumers

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.

Please note that fewer than 100 kits from the affected batch were supplied to retailers during a three week period, from 21 January to 11 February 2016.

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 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.

Information for health professionals

Please be aware of the above issue and advise patients accordingly if they seek advice.

If you have any questions or concerns about this issue, contact ConceivePlease on 02 8999 8060 or the sole distributor of these products, Health Direction, on 02 4655 8855.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA’s monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.