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We appreciate your time and attention to this important notification.ĪCCU-CHEK PERFORMA is a trademark of Roche.

Please inform your customer that users should call our Roche Diabetes Care Customer Care line as mentioned above, if they need any additional advice on the handling of the Accu-Chek ® Aviva / Accu-Chek ® Performa test strips or have any further questions or concerns. We sincerely apologize for any inconvenience this may cause and hope for your understanding and cooperation. Please also send us a copy of the communication to the authorities for our reference in case we need to support you further with any requests, and for record keeping. *For all other countries please visit our support page for local contactsĬommunications of this Field Safety NoticeĪs our local authorized distributor we would require you to inform your healthcare professionals, customers, retailers and users of the Accu-Chek ® Aviva / Accu-Chek ® Performa test strips about this field action and assure them that this is a rare occurrence and has only been identified in a hospital in the United States.Īdditionally, as the local authorized distributor of Roche Diabetes Care products, you are also required to check the local regulations and accordingly inform the relevant national competent authorities, if there is a need to do so. To obtain replacement from Roche Diabetes Care, please call our Roche Diabetes Care Customer Care line as shown below:

Roche Diabetes Care will provide test strip replacements to users who have purchased vials that were open within the sealed carton.

If you have any affected product, please refrain from using the concerned test strips.

Please do not perform control testing as instructed in the meter manual.

Anything prevents the cap from closing properly.

you see any damage to the cap or vial, or.

vial is open or damaged before using the test strips for the first time,.

Please inform your customers about the below mentioned instructions for users.Īctions to be taken by users of Accu-Chek ® Aviva / Accu-Chek ® Performa test strips 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.Īctions to be taken by the distributors and retailers Roche Diabetes Care is updating product labelling to clarify instructions for handling vials that have opened within sealed cartons. It is only when these two conditions occur in combination that the failure mode has been observed.ĭue to the influence of high temperature and humidity this failure might affect the accuracy of the blood glucose measurement. This could happen to Accu-Chek ® Aviva / Accu-Chek ® Performa test strips, when they are shipped at elevated temperature (≥45☌ or 113☏) AND when the carton is dropped or handled roughly during transit and distribution process. We have not had such complaints in the Middle East & Africa region. The Roche investigation showed that, in very rare circumstances, it is possible that a vial can open in a sealed carton while in transit.

Roche Diabetes Care has received complaints from one hospital in the United States alleging unexpected results (such as positively biased, or falsely too high, results) when using test strip vials which have opened while still in a sealed carton.

Important information about open vials of Accu-Chek ® Aviva / Accu-Chek ® Performa test stripsĭescription of Situation and Rationale giving rise to this corrective measure