Central Alerting System
View Alert


Originator: MHRA Medical Device Alerts

Issue date: 05-Jul-2018 13:08:30

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
  • Ofsted recipients
  • Social Care Providers (registered with CAS)
  • Special Health Authorities

Action category: Action

Title: Combur10 Test UX and Chemstrip 10 A test strips – risk of falsely low results when measuring test strips on the Urisys 1100 urine analyser.

Broadcast content:

Manufactured by Roche Diagnostics GmbH – Incorrect Limit of Detection (LoD) for protein, nitrite, ketone bodies, leukocytes, blood: intact erythrocytes, which may adversely impact patient treatment.

Please use the link below to access the spreadsheet:




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


Alert reference: MDA/2018/023

Action underway deadline: 19-Jul-2018

Action complete deadline: 02-Aug-2018

Attachments:

Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency