Medical Device Alert – Combur10 Test UX and Combur10 A test strips

05 Jul 2018

A medical device alert has been issued by the MHRA for affected LOT numbers of Combur10 Test UX and Combur10 A test strips.

MEDICAL DEVICE ALERT

Ref: MDA/2018/023

5 July 2018

Combur10 Test UX and Chemstrip 10 A test strips
(Manufactured by Roche Diagnostics Ltd)

A medical device alert has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for affected LOT numbers of Combur10 Test UX and Combur10 A test strips.

Affected test strips carry a risk of incorrect limit of detection (LoD) for blood: intact erythrocytes, ketone bodies, leukocytes, nitrite and protein; this may have a negative impact on patient treatment.

A list of the affected LOT numbers can be found in the urgent field safety notice.

Further information can be found on the MHRA section on the GOV.UK website.

Produced by NPA Pharmacy team July 2018.