Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to the US Food and Drug Administration communication on 10 June 2021, whether he has requested or received any advice on the efficacy of Innova Medical Group's SARS-CoV-2 Antigen Rapid Qualitative Test.

Following the safety notice issued on 10 June, the Medicines and Healthcare product Regulatory Agency (MHRA) requested briefing from the United States Food and Drug Administration, which confirmed it had no additional information.

NHS Test and Trace investigated whether the United Kingdom could be affected by any of the concerns raised and provided information to the MHRA. The MHRA confirmed it was satisfied with proposed actions to mitigate any risks.