Care homes and members of the public have been instructed by the government to immediately stop using coronavirus testing kits produced by a healthcare firm after safety problems were discovered.
Randox was awarded a £133m contract in March to produce the testing kits for England, Wales and Northern Ireland without any other firms being given the opportunity to bid for the work.
Under the contract, the kits are sent to the public and places such as care homes and then delivered back to Randox to check swabs to see if individuals have the virus.
In a statement, the Department of Health and Social Care said it had been “notified that some test kits produced by Randox laboratories may not meet our required safety standards for coronavirus testing”.
The DHSC did not explain the nature of the problem. It added: “As a precautionary measure and while we investigate further, NHS test and trace are requesting that all settings pause the use of Randox test kits with immediate effect and until further notice. The risk to safety is low and test results from Randox kits are not affected.”
The department said its instruction only “applies to unused Randox test kits, which are clearly marked with that name. Used Randox test kits can still be collected for processing as normal.”
In a statement, Randox said: “As an immediate precautionary measure we have temporarily suspended distribution of home sample collection kits using one particular batch/supplier of swabs. This is a temporary measure and does not apply to our private business which uses a different supplier of swabs.”
Jonathan Ashworth, the shadow health minister, tweeted: “Ministers overstated testing figures by 200,000 & now home testing kits don’t meet safety standards with use of all Randox test kits paused. Test & Trace costs £10 billion & increasingly chaotic with private firm after private firm failing to deliver.”
The owner of one care home received an email from the NHS on Thursday morning asking them to “store all of your unused Randox kits in a safe place to ensure that they are not used or mixed with other test kits, and one of our team will be in contact over the next week to confirm next steps”.
In May, the Guardian revealed Randox had been awarded the contract under fast-track arrangements. These enable public bodies dealing with the coronavirus to urgently award commercial contracts without asking other firms to bid for them.
Randox employs the Conservative politician Owen Paterson as a £100,000-a-year consultant. The former cabinet minister and leading Brexit supporter has been a consultant since 2015.
Previously Randox has not responded to questions about whether Paterson was involved in securing the contract. The Guardian did not receive a response when it asked Paterson for a response.
In May, Mark Menzies, the Conservative MP for Fylde in Lancashire, raised the issue of the Randox testing kits in parliament when he said a care home in his constituency, where half of the residents had died from coronavirus, could not secure testing for other residents.
Menzies said: “Six of the remaining residents are displaying symptoms, but they are being told that they will have to wait until mid-June for further tests, following errors made by Randox a few weeks ago.”
The health secretary, Matt Hancock, said at the time he would try to resolve the problem.