Tens of thousands of people in the UK could have been given a false negative PCR coronavirus test result, with most wrong tests originating from the south west of England.
NHS test and trace is now contacting those affected to ask them to take another Covid test and close contacts will also be advised to take a test.
The UK Health Securtity Agency (UKSA) says as many as 43,000 people may have been given false results, telling them they had a negative Covid test between September 8 and October 13.
The UKHSA have said the "isolated incident" took place at a lab in Wolverhampton, Immensa Health Clinic, with most wrong tests originating from the south west of England.
A full investigation is being carried out and there are no technical issues with test kits themselves and people should continue to test as normal, UKHSA said.
NHS Test and Trace estimates that around 400,000 samples have been processed through the lab, but new samples are now being redirected to other labs.
UKHSAD Public Health Incident Director Will Welfare said: “We have recently seen a rising number of positive LFD (lateral flow) results subsequently testing negative on PCR.
“As a result of our investigation, we are working with NHS Test and Trace and the company to determine the laboratory technical issues which have led to inaccurate PCR results being issued to people.
“We have immediately suspended testing at this laboratory while we continue the investigation.
“There is no evidence of any faults with LFD or PCR test kits themselves and the public should remain confident in using them and in other laboratory services currently provided.
“If you get a positive LFD test, it’s important to make sure that you then get a follow-up PCR test to confirm you have Covid-19.
“If you have symptoms of Covid-19, self-isolate and take a PCR test.”
Immensa Health Clinic Ltd. Chief Executive Andrea Riposati said: “We are fully collaborating with UKHSA on this matter.
“Quality is paramount for us. We have proudly analysed more than 2.5 million samples for NHS Test and Trace, working closely with the great teams at the Department for Health and UKHSA.
“We do not wish this matter or anything else to tarnish the amazing work done by the UK in this pandemic.”
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