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Clear & Simple faulty digital pregnancy tests recalled | Clear & Simple faulty digital pregnancy tests recalled |
(12 days later) | |
More than 58,000 digital pregnancy tests have been recalled after some wrongly told women they were expecting. | More than 58,000 digital pregnancy tests have been recalled after some wrongly told women they were expecting. |
Women who have bought the Clear & Simple test, manufactured by Guangzhou Wondfo Biotech, are being advised to return it. | Women who have bought the Clear & Simple test, manufactured by Guangzhou Wondfo Biotech, are being advised to return it. |
The Medicines and Healthcare products Regulatory Agency "strongly encourage" women to report issues with the test, which has been distributed in the UK. | The Medicines and Healthcare products Regulatory Agency "strongly encourage" women to report issues with the test, which has been distributed in the UK. |
The specific lot number of the affected tests is on and inside the packaging. | The specific lot number of the affected tests is on and inside the packaging. |
A recall notice from the manufacturer dated 1 September said this particular batch of tests was "producing a number of false positive results". | A recall notice from the manufacturer dated 1 September said this particular batch of tests was "producing a number of false positive results". |
Dr Duncan McPherson, clinical director of medical devices at the UK's Medicines and Healthcare products Regulatory Agency, said: "Patient safety is our highest priority. | Dr Duncan McPherson, clinical director of medical devices at the UK's Medicines and Healthcare products Regulatory Agency, said: "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. | "We strongly encourage anyone to report any issues with this product, or more generally with any medical device, to our Yellow Card Scheme. |
"If you have any questions about using digital pregnancy tests, please speak to your healthcare professional." | "If you have any questions about using digital pregnancy tests, please speak to your healthcare professional." |
Positive results in normal circumstances are almost always correct, the NHS advises, while a negative test result is less reliable. | Positive results in normal circumstances are almost always correct, the NHS advises, while a negative test result is less reliable. |