Safety Board Notification

Issue: Open vials of Accu-Chek® Performa test strips

Description of the situation: The Roche investigation showed that, in very rare circumstances, it is possible that a vial can open in a sealed carton while in transit. This could happen to Accu-Chek® Performa test strips, when they are shipped at elevated temperature ( ≥45°C or 113°F) AND when the carton is dropped or handled roughly during transit and distribution process. It is only when these two conditions occur in combination 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.

Affected product: Accu-Chek® Performa test strips (note: This issue is not lot or serial number specific and could affect also all SKUs)

Actions taken by Roche Diabetes Care: Roche Diabetes Care is updating product labeling to clarify instructions for handling vials that have opened within sealed cartons. Roche Diabetes Care will provide test strip replacements to users who have purchased test strip vials which have opened while still in a sealed carton.