Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to his Department's new story of 7 August 2020, Update on Randox test kits, which elements of Randox covid-19 tests did not meet required safety standards; and through what processes that determination was made.

The Medicines and Healthcare products Regulatory Agency (MHRA) reviewed the regulatory documents relating to Randox home sampling kits and revealed that documents for the swabs did not meet the regulatory requirements to support CE marking of the swab within the kit.

On 15 July the decision was made by the Department to pause the use of Randox kits pending further investigation.

Following confirmation from the Department that despite instruction to quarantine these kits, there were still cases of the kits being used. On 6 August 2020, the MHRA contacted Randox and asked them to conduct without delay a recall of those affected sampling kits which had been distributed to the United Kingdom in order to ensure that the kits are not used.

Randox communicated this action by means of a Field Safety Notice. The Department as a customer/recipient of the Field Safety Notice instructed their users to take the actions detailed in the Field Safety Notice.

Randox issued the Field Safety Notice on 7 August 2020.