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Coronavirus tests supplied by a Northern Ireland firm have been pulled over safety fears.
Health secretary Matt Hancock said during a statement in the House of Commons that the use of the Covid-19 testing kits is being “paused” across the UK.
The government confirmed the NHS Test and Trace service had been notified that some test kits produced by Randox Laboratories “may not meet our required safety standards for coronavirus testing”.
It said replacement kits would be sent “as soon as possible”.
Randox Laboratories, based in Crumlin, was awarded the £133 million contract by the Department for Health and Social Care (DHSC) in May after a non-competitive bidding process, the Mirror reports.
Health Secretary Matt Hancock told MPs in the House of Commons: “We’ve identified some test swabs that are not up to the usual high standard that we expect and we’ll be carrying out further testing of this batch.
“As a precautionary measure, and while we investigate further, we’re requesting the use of these Randox swab test kits are paused in all settings until further notice.
“This problem was brought to my attention yesterday afternoon, we contacted settings using these swabs last night and published the pause notice immediately.
“Clinical advice is that there’s no evidence of any harm, the test results are not affected, there is no evidence of any issues with our other test swabs and there is no impact on access to testing.”
Mr Hancock said the pause only applied to Randox test swabs and not any of the other companies involved in the four-nation deal which includes Thermo Fisher Scientific, Amazon, Boots, and Royal Mail.
Randox told the Guardian it had temporarily suspended distribution of home sample collection kits using one particular batch/supplier of swabs, “as an immediate precautionary measure”.
It said this did not apply to its private business, which it said uses a different supplier.
When asked by Jonathan Ashworth, the shadow health and social care secretary, what was wrong with the Randox batch, Mr Hancock said: “The reason is that they had a CE stamp and upon investigation of the certification of that stamp, the certification of that stamp was not forthcoming and therefore physical checks were done and we found that the swabs were not up to the standard that we expect.”
He added: “There is no evidence of any harm having been done.”
CE marking is required for many products and it shows that the manufacturer has checked that these products meetEUsafety, health or environmental requirements.
The Randox website says: “Our pioneering test for COVID-19 uses patented Randox Biochip Technology to accurately and reliably diagnose COVID-19, thus facilitating appropriate containment and reducing further spread of disease.
“The biochip comprises two tests for COVID-19; one specific and one confirmatory as recommended by the WHO.”
The update said Randox is responsible for 17% of the total tests carried out by the government’s national Covid-19 testing programme.
