Medical Device Alerts issued in May 2018

An alert was recently issued by MHRA on JM103 and JM105 Jaundice Meters. We also remind you of an alert about Accu-Chek blood glucose test strips.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 22 June 2018

• Therapeutic area: Anaesthesia and intensive care, Endocrinology, diabetology and metabolism, GI, hepatology and pancreatic disorders

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.

An alert was recent issued by MHRA on:

• JM103 and JM105 Jaundice Meters – risk of misinterpretation of measurement in hyperbilirubinemia cases

You are also reminded of the actions from the following alert, highlighted in Drug Safety Update in May 2018:

• Home use and Point of Care blood glucose monitoring system: Accu-Chek Aviva, Accu-Chek Performa and Accu-Chek Inform II test strips – risk of strip error messages and false high and low blood glucose results

Article citation: Drug Safety Update volume 11, issue 11; June 2018: 5

Published 22 June 2018