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.
- 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).