Thousands of pregnancy tests have been recalled amid fears they are giving false readings.
Health officials today warned Clear & Simple digital pregnancy tests may have incorrectly told women they are pregnant.
The Medicines and Healthcare products Regulatory Agency (MHRA) issued the alert this morning.
Health officials have advised women who have purchased Clear & Simple Digital Pregnancy Tests to check their product isn’t affected
The body, which polices the safety of medical products, has now urged all women who have bought one of the tests to check theirs isn’t affected.
Guangzhou Wondfo Biotech announced it was are recalling one lot of faulty Clear & Simple Digital Pregnancy Tests.
The manufacturer, based in Guangzhou in China, estimates more than 58,000 affected tests have been distributed in the UK.
In alert issued to Healthpoint, the distributor of the tests in the UK, the firm revealed how the test was producing false positive results.
Guangzhou Wondfo Biotech told the distributor an investigation showed the rib height of some test strip brackets were wrong.
It said this meant there was a large gap between the test strip bracket and the plastic enclosure of the digital pregnancy test.
In the alert, the firm added: ‘Therefore, it made a change in the light path of some products which eventually led to a larger signal value resulting in false positive results.’
The alert sent to Healthpoint on September 1. But the MHRA alert only came through today.
Healthpoint said the Clear & Simple digital pregnancy tests can be purchased at Bodycare and Poundworld, before the latter went bust.
The test is marketed as being 99.9 per cent accurate and giving results in just five minutes.
Women who have bought an affected Clear & Simple product should use other tests to determine if they are pregnant.
Dr Duncan McPherson, MHRA’s clinical director of medical devices, said any affected tests can be returned to wherever they were bought from.
He added: ‘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 Clear & Simple Digital Pregnancy Tests that have been affected have the lot number DM10220170710E and expire in January 2020.
The MHRA has issued alerts over a string of faulty products in the past few months, including 10 batches of Durex condoms.
The condom firm warned the affected condoms could burst during sex.
And the MHRA in July also issued a recall of scores of faulty tourniquets that may not have stopped patients from bleeding to death.
First responders and hikers were urged to check if they have a SAM XT Extremity Tourniquet.
A problem in the sewing of the gadget may have caused the seam holding the buckle to the belt to fail when used to stop blood flow.
And the month before it recalled 200,000 bottles of blackcurrant cough syrups for children sold in supermarkets.
Parents were urged to return any affected own-brand bottles at Tesco, Asda, Wilko, Sainsbury’s and Morrisons, amid fears they may contain mould.
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