The UK Health Security Agency (UKHSA) have said that 43,000 people could have been given the wrong negative PCR Covid test results.
Testing operations provided by Immensa Health Clinic Ltd at its laboratory in Wolverhampton have now been suspended following an investigation.
The errors in the results are mainly focused to the South West of England between 8 September and 12 October.
Dr Will Welfare, public health incident director at UKHSA, 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.”
Andrea Riposati, chief executive of Immensa Health Clinic Ltd, 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.”