Thousands of pregnancy testing kits recalled over faulty results

THOUSANDS of pregnancy testing kits are being recalled after women were wrongly informed they were expecting.

About 60,000 of the potentially faulty Clear & Simple digital pregnancy tests have been distributed in the UK and an unknown number have been found to give a false positive result.

China-based manufacturer Guangzhou Wondfo Biotech announced the recall following an investigation, admitting that a production error had led to its results “misleading consumers”. The Medicines and Healthcare products Regulatory Agency (MHRA) has urged women who might have bought the test to check the lot number and expiry date to determine if it is among those affected.

Dr Duncan Mcpherson, director of clinical devices at the MHRA, said: “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.” The batch was manufactured last July and has been available in the UK since last November. The test’s packaging claims that it is “over 99 per cent accurate”, with a “clear digital reading” and results in five minutes.

Several customers raised concerns about the reliability of the product earlier this year. One, writing on an online parents forum, said she was feeling “confused” after a Clear & Simple test came back positive while another brand gave a negative result. Several others said they had received false positive results from the brand.

One customer even suggested there might be a faulty batch and another woman stated in August that the company had responded to her complaint, admitting that it was “aware of false positives happening”.

Healthpoint, the UK distributor of the test, said affected stocks had been removed from shops and chemists and would be destroyed.

Guangzhou Wondfo Biotech said it had decided not to take further action beyond the recall as the information leaflets that accompany the tests advise customers to talk to a doctor who will tell them what to do next in the event of a positive result.

The NHS states that a positive test result is “almost certainly correct”, while “a negative result is less reliable”.

In July, Asda apologised after four of its pregnancy tests returned false results, leading a woman to wrongly believe she was expecting her first child.

The 25-year-old, from Plymouth, told her partner and wider family that she was pregnant only to discover the tests, which claim to be 99 per cent accurate, were all wrong.

Several other customers left similar reviews on the company’s website claiming that they too had been given false positive results. Asda insisted that its two-pack of digital tests was quality tested and a spokesman said it would continue to sell the product.

The Clear & Simple product recall applies to single, digital tests with a batch number of DM10220170710E and expiry date of January 2020.