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More Roche strips added to recall

By Editor
22nd May 2018
Medical devices

Another set of test strips have been added to the Roche recall due to risk of error messages.

Last week, the company said selected lots of its Accu-Chek® Aviva and Accu-Chek Performa test strips are potentially showing an increased number of strip errors prior to dosing or biased results.

The Medicines and Healthcare products Regulatory Agency (MHRA) has now said that the Accu-Chek Inform II test strips are also affected.

The company is carrying out a wholesale recall of certain batches of the products after problems were picked up during the manufacturing process, as reported by the DT earlier this month.

A letter issued through the MHRA said: “At Roche Diabetes Care we hold our products to the highest standards of quality and are committed to communicating any issues impacting the operation of our products. This is why we would like to inform you today about an issue that might occur in certain lots of the Accu-Chek Aviva , Accu-Chek Performa test strips, and Accu-Chek Performa strips that have been included in Accu-Chek Performa Nano meter kits.

“As part of our ongoing quality monitoring and market surveillance processes, we have identified certain test strip lots that potentially show an increase in strip errors prior to dosing. Due to the designed fail-safe in the blood glucose meter, the issue can be identified by an error message displayed on the meter upon strip insertion or through the device not recognising the test strip. However, in a very limited number of cases the test strip can produce a biased result i.e. a falsely too high or too low value, which you might not be able to detect easily and which could lead to incorrect therapy adaptations.”

For a list of all of the affected UK products, read our story from last week.

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