Nearly 60,000 pregnancy tests sold in the UK are being recalled due to a "small number" of false positives being reported after using the Clear & Simple digital brand.
In a statement issued yesterday on their website, distributor Healthpoint said that although the majority of users have received authentic results, there have been some who have received inaccurate ones from a particular lot (lot number DM10220170710E with an expiry date of January 9, 2020). As a result of these reported inaccuracies, the kits - which have been available in the UK since last November - have been pulled off the shelves and customers have been urged to return them and seek alternative testing methods.
"We are very sorry for any inconvenience and upset that this manufacturing fault may have caused," Healthpoint said in their statement. "We are working closely with the manufacturer to ensure the accuracy of future supplies."
The affected tests were manufactured in July 2017 by Guangzhou Wondfo Biotech, a high-tech biological company headquartered in China that specializes in rapid diagnostics. The regulatory body that oversees medical devices and drugs in the UK, The Medicines and Healthcare products Regulatory Agency (MHRA), said that it was notified of the problem in early September.
"When 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," a spokesperson said.
Interestingly, earlier this year, a UK-based parenting forum had several inquiries from women who seemed to be questioning the accuracy of the very same Clear & Simple digital brand when they too, received positive results. One tester even took apart her test to inspect whether or not the result was accurate - and found that it wasn't.
"I thought your [sic] meant to have 2 lines if it’s positive? So confused." she wrote, showing how the internal test clearly showed one line when there should have been two.
Clear & Simple isn't the first brand to recently come under fire for delivering inaccurate results. Just last year, a woman in the UK received three false-positive digital response results from the Asda brand of pregnancy tests. After discovering other women had experienced similar problems with the brand, she complained to the store directly but ended up waiting four months for a refund.
What's worse, claims Rebecca Barratt, is that when she eventually received a gift card from the store, it came with a note stating that she could use the money to buy herself some flowers.
"We’re truly sorry for this situation and understand how upsetting it will have been," a spokesperson said of the incident.