A field safety notice has been issued by Roche Diabetes Care over their Accu-Chek Aviva and Accu-Chek Performa test strips.
The company has received complaints from a hospital in the United States reporting unexpected results when using test strip vials which have opened while still in a sealed carton.
A later investigation by Roche showed that, in ‘very rare’ circumstances, it is possible that a vial can open in a sealed carton while in transit.
The issue can affect the Accu-Chek Aviva and Accu-Chek Performa test strips. The issue happens when they are shipped at high temperatures and when the carton is dropped or handled roughly during the transit and distribution process.
A statement from Roche said: “It is only when these two conditions happen together that the failure mode has been observed. Due to the influence of high temperature and humidity, this failure might affect the accuracy of the blood glucose measurement.”
Roche Diabetes Care is updating the labels of its products with instructions for handling vials that have opened within sealed cartons. If you've bought test strip vials which have opened, the company will provide replacements.
Advice has been issued for anyone with using Accu-Chek Aviva or Accu-Chek Performa test strips saying they should:
- Always inspect the vials before use.
- Not use the test strips, or perform control testing, if a vial is open or damaged before using the test strips for the first time. Also do not use if the cap is not fully closed or you see any damage to the cap or vial, or anything prevents the cap from closing properly.
Anyone with any affected product should dispose of the test strips immediately. Roche Diabetes Care will provide test strip replacements to users who have purchased vials that were open within the sealed carton.
To get a replacement from Roche Diabetes Care, call their Customer Careline on 0800 701 000.
