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Originator: MHRA Medical Device Alerts

Issue date: 01-May-2018 15:00:33

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
  • Special Health Authorities

Action category: Immediate Action

Title: cobas b 221 instruments with AutoQC module - software limitation affecting automatic QC measurements

Broadcast content: Manufactured by Roche Diagnostics GmbH – Under specific circumstances scheduled automatic QC measurements may no longer be performed and erroneous patient results may remain undetected.

Additional information: Do not cascade to Primary Care

Alert reference: MDA/2018/013

Action underway deadline: 16-May-2018

Action complete deadline: 01-Jun-2018


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency