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Home testing Covid-19 kits made by private lab recalled after MHRA warning

Covid-19 home testing kits used as part of the NHS testing system have been recalled following a warning from the Medicines and Healthcare products Regulatory Agency.

Last month the Government temporarily paused the use of the kits, produced by private firm Randox Laboratories, while safety concerns were investigated.

The MHRA has now said all stocks of Randox Covid-19 home testing kits should no longer be used and the kits – which have a catalogue number of EV4429 – should be returned to Randox Laboratories. 

In a statement, the Department of Health and Social Care reiterated the risk to safety is low and that test results from Randox kits are not affected.

They added: ‘We have been supporting all testing settings to receive replacement kits as soon as possible.’

A spokesperson for Randox said the problems stemmed from kits having incomplete safety certification, which was not provided by its external supplier of swabs.

The spokesperson said: ‘To date, Randox have not been provided with evidence to satisfactorily support the CE marking for these swabs. So, noting the lack of CE certification by the supplier and that some kits remain in the field at this time Randox has, as a regulatory measure, initiated the recall of those kits used within the national testing programme.’

They added: ‘Randox Laboratories will continue to provide high volume Covid-19 testing to the national testing programme from their laboratories, based on sample collection kits from other providers.’

They said that the recall applies only to sample collection kits within the UK National Test and Trace Programme and that Randox kits provided privately are not affected.

The spokesperson did not confirm how many testing kits were being recalled.

The DHSC statement said: ‘The Medicines and Healthcare products Regulatory Agency has instructed Randox to recall the ‘Randox Covid-19 Home Testing Kit’ with the catalogue number EV4429 from NHS Test and Trace testing settings.

‘This decision has been taken as a precautionary measure to prevent any further use of these Randox tests.’