Roche Diabetes Care test strip errors leads to recall

Roche Diabetes Care test strip errors has led to a recall of a number of home-use and point-of-care glucose monitoring systems.

The Roche Diabetes Care test strip errors are for the following systems: Accu-Chek Aviva; Accu-Chek Performa; and Accu-Chek Inform II.

There is a risk of a strip error message that may lead to either falsely high or falsely low blood glucose results reported.

Roche Diabetes Care test strip errors could cause harm to users

The Roche Diabetes Care test strip errors could cause harm to users as the testing strips are used to monitor glucose levels prior to dosing the blood. As well as potentially producing falsely high or falsely low results, there is also a reported risk of strips producing error messages as well.

Some of the incorrect readings may also be hard to detect, further increasing potential risks to users.

Field Safety Notice issued

According to the Field Safety Notice issued, The Roche Diabetes Care test strip errors were identified as part of quality monitoring and market surveillance.

The affected products in the UK are listed as follows:

• Accu-Chek Aviva 50s
• Accu-Chek Aviva 10s (Sold in retail only)
• Accu-Chek Performa 10s (Sold in retail only)
• Accu-Chek Performa 10s contained with Accu-Chek Performa Nano meter kits

You can view the full Field Safety Notice here.

MHRA alert

The Medicines and Healthcare products Regulatory Agency (MHRA) issued a recall and warning over the issues with the Roche Diabetes Care test strip errors last month. As some of the products can be purchased and used at home, there may be a greater risk to those patients unless they are contacted and warned about the issues.

Healthcare professionals and services will receive the Field Safety Notice, but the people using the strips at home will need to be contacted as well.