Clear & Simple Digital Pregnancy Tests following the tests producing a small number of false positive results. Image: Open Government Licence v3.0

Inaccurate results from some Clear & Simple Digital Pregnancy Tests

Guangzhou Wondfo Biotech has announced that they are recalling one batch of faulty Clear & Simple Digital Pregnancy Tests following some tests producing a small number of false positive results.

The batch number can be found on the end of the box and is also printed on the sachet. Only this batch is affected and the information is shown below:

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

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