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Originator: MHRA Medical Device Alerts

Issue date: 08-Jun-2020 10:04:22

This alert has been issued to:
  • Care Trusts
  • Mental Health Trusts
  • Specialists Trusts
  • NHS Regional Offices
  • Learning Disabilities Trusts
  • Mental Health & Social Care Trusts
  • Ambulance Trusts
  • Mental Health & Learning Disabilities Trusts
  • Acute Trusts
  • Community Trusts

  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • NHS Foundation Trusts (England) - Medical Director
  • NHS Foundation Trusts (England) - Chief Executive
  • Special Health Authorities
  • NHS Trusts (England) - Medical Director
  • CMO Urgent Messages - Non-NHS Recipients on Public Health Link
  • Regional Directors of Public Health
  • CMO Urgent Messages - Recipients on Public Health Link
  • Director of Public Health
  • NHS Trusts (England) - Chief Executive
  • GP - Locum
  • NHS 111 and Out of hours providers
  • GP Practices
  • Primary Care Networks

Action category: Action

Title: Results from laboratory based tests for COVID-19 antibodies using capillary blood sample collection kits may not be reliable

Broadcast content: This alert covers issues with both laboratory based tests for COVID-19 antibodies (unvalidated sample type) and capillary blood sample collection kits (unvalidated for home use).

Given this relates to COVID-19 we have sent this alert to a broader mailing list than would usually receive a Medical Device Alert via CAS. 

Additional information: This Medical Device Alert is being sent to GPs for information only, in circumstances where patients may seek advice about the contents of this notice. GPs need take no further action on receipt of this alert.
NHS England and NHS Improvement Regional offices: please cascade this alert to community pharmacy.

Alert reference: MDA/2020/015

Action underway deadline: 15-Jun-2020

Action complete deadline: 13-Jul-2020


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency