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Home Pregnancy Test Kits Recalled

Therapeutic Good Australia (TGA) has released a statement confirming that several pregnancy tests have been taken off the market due to being inaccurate or unreliable.  A number of tests were found to have a manufacturing fault, which has since been rectified.

In March 2017 a family planning clinic reported a number of defective tests, prompting an inquiry from the TGA into home pregnancy test kits. These test kits test for levels of the pregnancy hormone human chorionic gonadotropin (hCG). The TGA completed a review of all hCG self-test kits to ensure that the products were doing what they claimed to do.

Some of the test kits returned inaccurate results, or were unreliable. These test kits have been removed from sale, and subsequently cancelled from the Australian Register of Therapeutic Goods (ARTG).

All devices that remain for sale in the Australian market were found to work correctly and reliably. Twenty seven pregnancy test kits were tested by the TGA for the adequate detection of hCG, the degree of sensitivity to hCG and if the labeling reflected the test results. Of the 27 kits tested, 22 were found to work accurately and provide reliable results.

One product in particular (First Response Digital from Church and Dwight) could not be tested as it was found to have too many defective devices. Investigation has since revealed a manufacturing fault, which has now been corrected. Since correcting the manufacturing fault the device has been retested, has passed TGA testing and is available for sale.

The following test kits failed the TGA testing:

  • One Step Pregnancy test – removed from sale by manufacturer
  • Pregsure test strips – recalled and removed from sale
  • PregSure digital – recalled and removed from sale
  • QuickVue One-Step hCG urine test kit – removed from sale by manufacturer
  • First Response Digital Pregnancy Test/First Response Test & Reassure – manufacturing fault corrected, passed subsequent TGA testing.

It is important that consumers remember that all home pregnancy test kits available for sale have been tested and found to be fit for purpose. However, if you receive a positive pregnancy test it is important to have your pregnancy confirmed by your GP.

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