View Alert
Originator: MHRA Medical Device Alerts

Issue date: 08-Oct-2018 14:39:59

Action by recipients:
  • Acute Trusts
  • Learning Disabilities Trusts
  • Mental Health & Learning Disabilities
  • Community Trusts
  • Care Trusts
  • Mental Health & Social Care Trusts
  • Ambulance Trusts
  • Mental Health Trusts
  • Specialists Trusts
  • NHS Regional Offices

Information to recipients:
  • Special Health Authorities
  • Other contacts
  • Social Care Providers (registered with CAS)
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups

Action category: Action

Title: CoaguChek Test Strips for Point of Care and Home Use – risk of false high results

Broadcast content: Manufactured by Roche Diagnostics GmbH: affected CoaguChek test strips may give false high results for INR values above 4.5 when compared to laboratory results, this may lead to incorrect treatment decisions

Additional information: NHS Regional Offices:
Please cascade to primary care


Alert reference: MDA/2018/033

Action underway deadline: 15-Oct-2018

Action complete deadline: 22-Oct-2018

Attachments:

Contact our helpdesk

Telephone: 020 3080 6747
Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency