Mums The One one step hCG urine pregnancy test

Recall – potential decreased sensitivity and risk of false negative results

10 March 2016

Consumers and health professionals are advised that Mums The One (trading as PregnancyShop.com.au), in consultation with the TGA, is recalling one batch of Mums The One one step human chorionic gonadotropin (hCG) urine pregnancy tests. The affected batch number is 20151106.

TGA testing of Mums The One one step hCG urine pregnancy tests from the affected batch found that these tests do not meet a claim made in the product documentation. Specifically, these tests failed to detect hCG at concentrations of 10 mIU/mL, 25 mIU/mL and 50 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

Please note that Mums The One one step hCG urine pregnancy tests were sold exclusively through the PregnancyShop.com.au website. The affected batch was supplied to customers between 12 November 2015 and 8 January 2016.

If you have any unused Mums The One 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 20151106, contact PregnancyShop.com.au for a refund.

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 Mums The One one step hCG pregnancy test from the affected batch, it is recommended that you retest with a different product.

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 Mums The One by email at recall@mumstheone.com.au or phone 02 6299 1996.

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.