Safety Notice for Accu-Check Aviva Users

Do you use Accu-Chek Aviva meter and test strips? You should urgently read this safety notice!

 

Accu-Chek (Roche) has sent an urgent notice about some test strips boxes. Some of the opened PLASTIC test strips vials have opened while still in a sealed carton. As per Manufacturer’s note, it can happen only when the carton is dropped or handled roughly during the transit at elevated temperatures (≥45°C or 113°F). There is evidence, that if this rare event occurs, it might affect the accuracy of the blood glucose measurement.

 

If you opened the carton box, and you have noticed that your blood glucose test strips plastic vial is opened DO NOT USE THE STRIPS.

 

Actions to be taken by users of Accu-Chek Aviva test strips:

  • Users are advised to always inspect vials of Accu-Chek Aviva test strips before use.
  • Please, do not use the test strips if o vial is open or damaged before using the test strips for the first time, o the cap is not fully closed o you see any damage to the cap or vial, or o anything prevents the cap from closing properly.
  • Please do not perform control testing as instructed in the meter manual.
  • If you have any affected product, please 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 obtain replacement from Roche Diabetes Care, please call Roche Diabetes Care Customer Careline on 1 800 709 600.

 

 

This Safety Notice is also available on the HPRA website www.hpra.ie