Medical Device Alerts issued in October 2018
An alert was recently issued by MHRA about CoaguChek Test Strips for Point of Care and Home Use due to a risk of false high results. Affected CoaguChek test strips may give false high results for INR values above 4.5 when compared to laboratory results, which may lead to incorrect treatment decisions.
In this monthly update, we highlight selected Medical Device Alerts that have been issued recently by MHRA. Please note, this is not an exhaustive list of medical device alerts. For all Medical Device Alerts from MHRA, see Alerts and recalls for drugs and medical devices.
The following alert was recently issued:
- CoaguChek Test Strips for Point of Care and Home Use – risk of false high results (MDA/2018/033). Issued 8 October 2018. Manufactured by Roche Diagnostics GmbH: affected CoaguChek test strips may give false high results for INR values above 4.5 when compared to laboratory results, this may lead to incorrect treatment decisions
You should also be aware of the recent recall of Clear and Simple Digital Pregnancy Tests (lot DM10220170710E) due to a small number of false positive results, see Field Safety Notice and MHRA press release for more information.
Article citation: Drug Safety Update volume 12, issue 4: November 2018: 6.