Faulty digital pregnancy tests recalled over ‘false positive’ results


Thousands of digital pregnancy test kits have been recalled in the United Kingdom after women were given false positive results.


People using Guangzhou Wondfo Biotech’s test kit Clear & Simple were advised to check the lot number to see if it belongs to the defaulted ones. If it is from batch of those affected then you should immediately return it.


It is estimated that more than 58,000 default test kits have been distributed in the UK.


The lot number of the affected tests is.

Description – Clear and Simple Digital Pregnancy Test
Catalogue Number – DM-102
Lot Number – DM10220170710E
Expiry Date – January 2020

The Medicines and Healthcare products Regulatory Agency (MHRA) has advised users to women to use alternative testing methods and refer any affected tests to their pharmacy or shop.


A MHRA spokesman said: “Guangzhou Wondfo Biotech has announced that they are recalling one lot of faulty Clear & Simple Digital Pregnancy Tests following the tests producing a small number of false positive results.

“Anyone who has purchased an affected test is advised to seek alternative testing methods and return affected tests to their pharmacy or shop.”


According to the company, the batch was manufactured last July and was available in the stores since last November. The company claims that the test’s packaging is “over 99 per cent accurate.”

The director of clinical devices at the MHRA, Dr Duncan McPherson, said: “If you have any questions about using digital pregnancy tests, please speak to your healthcare professional. Patient safety is our highest priority. We strongly encourage anyone to report any issues with this product.”




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