England: 750,000 CV-19 test kits recalled, ‘may not meet safety standards’

August 8, 2020 | By Hugh Pym | BBC News |

Coronavirus: Randox recalls up to 750,000 test kits over safety concerns

A care home resident is tested for coronavirus
Image copyright PA MEDIA

“Up to 750,000 unused coronavirus testing kits are being recalled due to safety concerns.

The UK’s medicines and healthcare products regulator (MHRA) asked Randox to recall the kits sent out to care homes and individuals.

The government said it was a “precautionary measure” and the risk to safety was low.

It comes weeks after the health secretary said Randox kits should not be used until further notice.

In mid-July, Matt Hancock said the swabs in some kits were “not up to standard”.

The Department for Health and Social Care said results from Randox tests were unaffected.

A spokeswoman said: “We have high safety standards for all coronavirus tests. Following the pausing of Randox kits on 15 July, Randox have now recalled all test kits as a precautionary measure.”

Care home residents or staff with symptoms of coronavirus can continue to book a test, she said.

Last weekend, a pledge to provide regular testing for care home residents and staff in England was delayed, partly because of the problems with Randox kits.

Healthcare group Randox, based in County Antrim in Northern Ireland, claims to be responsible for up to 17% of the total tests carried out in the UK. About 1.3 million of its tests have been sent out so far.

Around 200,000 coronavirus tests are now being provided across the UK each day.

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Another awkward development’

Analysis box by Hugh Pym, health editor

Problems with Randox tests were flagged up in July, with supplies to care homes and individuals halted.

The Department of Health has stressed that the safety risk is low and recalling the kits is a precautionary measure to remove the possibility of them being used in error.

But this is another awkward development for the test and trace programme in England when it is trying to expand capacity rapidly.

The Randox issue was one factor behind a recent decision to delay a pledge to provide regular testing for care home staff and residents in England.

After questions have been raised about procurement of personal protective equipment (PPE), there will now be more about government contracts for testing provision.”


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July 16, 2020

Some Randox test kits ‘may not meet safety standards’

Woman having throat swab taken
Image copyright GETTY IMAGES

“The swabs in some batches of one brand of coronavirus home-test kits are “not up to standard”, Health Secretary Matt Hancock has said.

As a precaution, the government says the kits made by Randox should not be used until further notice.

There is no evidence of harm being done and no impact on access to testing, Mr Hancock said.

Randox claims to be responsible for up to 17% of the total tests carried out in the UK.

The company is a healthcare diagnostics group based out of County Antrim in Northern Ireland.

The swabs are used to collect a sample from the back of the throat and nose, which is then sent to a lab to test for the virus.

Mr Hancock told the Commons he was contacted on Wednesday afternoon about the problem.

He said the certification behind the CE safety mark on the product was “not forthcoming”.

In a statement earlier on Thursday, the Department of Health and Social Care said: “The risk to safety is low and test results from Randox kits are not affected.”

It said it would be “supporting all testing settings to receive replacement kits as soon as possible”.

Tests kits produced by Randox Laboratories, which have been used in care homes and sent to people at home, are clearly marked with the company’s name.

Kits that have already been used can still be collected for processing as normal.

Baroness Dido Harding, head of NHS Test and Trace in England, which has a separate contract with Randox, said it was too early to comment on the impact of the safety issue, but she said test results were “not affected”.”

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