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a alert imageJuly 6 2018

A medical device alert has been issued regarding a risk of false results when using Combur10 Test UX and Chemstrip 10 A test strips. Specifically, there is a potential risk of falsely low results when using the measuring test strips on the Urisys 1100 urine analyser.

Manufacturer Roche Diagnostics has identified incorrect Limits of Detection (LoD) for protein, nitrite, ketone bodies, leukocytes, and blood (intact erythrocytes), which may adversely impact patient treatment. 

A Field Safety Notice shows the updated LoD quantities for the test strips. Roche Diagnostics asks users to “be aware of the changed limits of detection in the method sheet of the test strip products for each individual test parameter.”

It has also provided a workaround which should be performed until further notice: “In case the Urisys 1100 is reporting negative results for protein, nitrite, ketone bodies, leukocytes or blood (intact erythrocytes), please verify the result by visual reading, using the colour scale provided on the test strip vial. In case of discrepant values, the visually determined value shall be reported.”

In the alert, the MHRA has said: “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).”

Link:
MHRA alert       

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