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Medical Device Alert - Combur10 Test UX and Chemstrip 10 A test strips

Posted: 06.07.2018

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

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. 

Action: 

  • Identify affected devices, which are listed in the manufacturer’s Field Safety Notice (FSN)
  • Ensure all relevant members of staff receive the manufacturer’s FSN and that they understand the problem and actions to be taken.
  • Follow the manufacturer’s workaround until advised otherwise by the manufacturer.
  • If any adverse event occurs relating to this issue please report this to MHRA via Yellow Card or the relevant devolved administrations (Scotland, Wales and Northern Ireland).  

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