Press release

Digital pregnancy tests recalled in new alert amid false positive results

People who have purchased Clear & Simple Digital Pregnancy Tests are advised to check the lot number after some tests have returned inaccurate results.

Clear&Simple

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. See the alert for more information.

People are advised to check if they have any of the affected tests, which are listed in the table below. The lot number can be found on the end of the box and is also printed on the sachet. Only this lot number is affected.

The manufacturer estimates more than 58,000 affected tests have been distributed in the UK.

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

Dr Duncan McPherson, MHRA’s Clinical Director of Medical Devices, said:

It is important people check the lot number of any Clear & Simple Digital Pregnancy Tests they have purchased to see if they have a product from an affected lot.

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, or more generally with any medical device, to our Yellow Card Scheme.

The affected lot number is listed below:

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

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Published 4 October 2018