Thousands of women are feared to have been falsely told they are pregnant after taking faulty tests.
Officials today warned 58,000 faulty Clear & Simple digital pregnancy tests were being recalled by the Chinese manufacturer.
The Medicines and Healthcare products Regulatory Agency (MHRA) announced a batch of the tests were giving out false positive readings.
It issued the alert about the manufacturing error this morning. But the body, which polices the safety of medical products, today admitted it received notice of the recall a month ago.
MailOnline has already been contacted by one woman, who was devastated when her ‘positive’ Clear & Simple pregnancy test allegedly turned out to be false.
The 22-year-old restaurant worker said her boyfriend was ‘so happy’ when they found out the news and added they were in the ‘right situation’ to start a family.
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, which usually retail for between £3 and £4.
The manufacturer, based in Guangzhou in China, estimates more than 58,000 affected tests have been distributed in the UK.
In an 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 was sent to Healthpoint on September 1. But the MHRA alert only came through today. It is unsure if tests in other countries are affected.
A spokesperson for the MHRA told MailOnline it received notice from Healthpoint on September 7.
They added: ‘As soon as MHRA received the notification from the manufacturer we began our own internal processes to clarify the situation, including working out the magnitude of the issue and potential risks to public health.
‘This understandably took some time.
‘At MHRA we need to make sure our response to any report of device faults is proportionate and pragmatic.’
Officials issued the alert about the manufacturing error this morning. However, the body today admitted it received notice of the recall a month ago (pictured: a letter from the manufacturer to Healthpoint, the distributor of the tests in the UK)
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 percent accurate and giving results in just five minutes.
Home pregnancy tests detect a hormone called beta-human chorionic gonadotropin (HCG) found in the blood and the urine which is produced by the developing placenta.
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 that could burst during sex.
And in July it also issued a recall of scores of faulty tourniquets that may not have stopped patients from bleeding to death.
The month before it recalled 200,000 bottles of blackcurrant cough syrups for children sold in supermarkets.
If you know someone who might like this, please click “Share”!
