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Thursday, 4 October 2018

Thousands of women are falsely told they're PREGNANT by faulty Clear & Simple tests as it's revealed it took a MONTH for officials to announce recall

  • The Medicines and Healthcare products Regulatory Agency issued the alert
  • The body urged women to check their tests aren't affected before using them
  • Do you think you've been given a false reading from one of the tests? Email stephen.matthews@mailonline.co.uk
Thousands of women are feared to have been falsely told they are pregnant after taking faulty tests sold on the high street.  
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
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 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)
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)

RESTAURANT WORKER, 22, WAS LEFT DEVASTATED WHEN HER 'POSITIVE' CLEAR & SIMPLE PREGNANCY TEST TURNED OUT TO BE FALSE

A restaurant worker was left devastated when her 'positive' Clear & Simple pregnancy test allegedly turned out to be false.
The woman, who chose to remain anonymous, bought the test for around £2.99 from Home Bargains in July after she came off the pill and missed a period.
After being told she could not get a GP appointment for the next two weeks and suffering from severe abdominal pain, she called the non-emergency number NHS 111.
Concerned she became pregnant so quickly after coming off the pill, NHS workers told the 22-year-old she may be suffering from an ectopic pregnancy and urged her to go to hospital immediately.
Although the woman, from Rossendale, Lancashire, and her 26-year-old boyfriend had not been trying for a baby, they had discussed starting a family in the past and were excited by the 'positive' result.
'My boyfriend was really happy, he’s ready for children,' she told MailOnline. 'We both work full time, we have a mortgage, we’re in the right situation for it.' 
Once at hospital, she spent more than eight hours doing urine and blood tests before being told she was not pregnant.
'The whole thing was so nerve-racking,' she said. 'Ectopic pregnancies are so dangerous and often need surgery to be removed so it was scary.'
Ectopic pregnancies occur when a fertilised egg implants itself outside of the womb, usually in one of the fallopian tubes.  
She added: 'The box said it was 99.9 per cent accurate so I expected the result to be true. I feel really let down and I’ll never ever use that brand again.' 
HOW DO I KNOW IF MY PREGNANCY TEST IS AFFECTED? 
Guangzhou Wondfo Biotech announced it was are recalling one lot of faulty Clear & Simple Digital Pregnancy Tests.
The manufacturer estimates more than 58,000 affected tests have been distributed in the UK.
The MHRA said the affected Clear & Simple Digital Pregnancy Tests have the catalogue number DM-102.
Officials warned they also have the lot number  DM10220170710E and expire in January 2020. 
Why are the tests giving false positive readings? 
In alert dated September 1 and sent 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.'
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. 
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. 

WOMAN, 30, CRAVING A CHILD WITH HER PARTNER TELLS OF THE 'AWFUL' MOMENT SHE FOUND OUT SHE WASN'T PREGNANT 

A 30-year-old woman craving a child with her partner said her world came crashing down after getting several false positive readings from Clear & Simple digital pregnancy tests.
The sales manager, who wanted to remain anonymous, today told MailOnline she took one of the firm’s tests at the end of March after missing her period. It told her she was expecting.
The woman, who has been with her 30-year-old partner for two years, took several more of the tests, which she bought in Home Bargains because they were cheap. Only one gave her a negative result.
Believing she was expecting her first child, the woman, from Leeds, tried to book in with a doctor – but struggled and eventually went private to have a scan at the nine-week mark.
Their tests showed her womb was ‘empty’ – despite them believing she was pregnant because of the numerous tests that came back positive. Eventually she was told there was no pregnancy.
The woman told MailOnline: ‘We had been trying for 18 months. 
'I had got to a comfortable age in my life... it seemed like right time to expand the family and have a child of my mine.'
Commenting on when she found out she wasn't actually pregnant, she said: 'It was awful, it was like having a miscarriage.'

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