Matt Hancock orders pause in use of sub-standard coronavirus testing swabs

Health secretary tells MPs there is no evidence of clinical harm to patients

Health secretary Matt Hancock has ordered a halt to the use of Randox-branded coronavirus testing kits after swabs were found not to be up to required standards.

Mr Hancock told the House of Commons that there was no evidence of clinical harm to patients or of the results of tests being invalidated by use of the sub-standard equipment.

The award in March of a £133 million contract for testing kits to the Northern Ireland-based company caused controversy when official documents indicated that it was awarded without a competitive process.

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 department said its instruction applies only to "unused Randox test kits, which are clearly marked with that name. Used Randox test kits can still be collected for processing as normal.”

Explaining the decision in a statement to the Commons, Mr Hancock said: “We've identified some swabs that are not up to the usual high standard that we expect and will be carrying out further testing of this batch as a proposed precautionary measure," said the health secretary.

“While we investigate further, we're requesting that 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 is no evidence of any harm, the test results are not affected. There is no evidence of issues with any of our other test swabs, and there is no impact on access to testing."

Shadow health secretary Jonathan Ashworth asked the health secretary what was wrong with the Randox test kits and how many had been used.

“Is there a health risk to anyone who has been tested with these kits?" asked Mr Ashworth. "And how many people have these unsafe kits been used on and why weren’t the certifications checked before these kits were used?

“These kits tend to be used in many care homes. We want care home residents to be tested regularly, we want care home staff to be tested regularly – can he guarantee that those care homes will now get alternative kits rapidly?”

Mr Hancock replied: “The reason is that they had a CE stamp and upon investigation of the certification of that stamp the certification was not forthcoming, and therefore physical checks were done and we found that the swabs weren’t up to the standards that we expect.

“This is limited to the Randox element of the testing system, not the broader testing system that we have, and I explained the clinical position which is that there is no evidence of any harm having been done and that there is full access to testing because we have plenty of other test kits available.”