I received this email this morning. I doubt it will affect any of us but just in case I thought I would share it. I checked online and it's genuine and relates to the UK as well as the US
Urgent Field Safety Notice
Manufacturer’s reference: SB_RDC_2021_03
SRN number: DE-MF-000006276
ACC-0014842200
Burgess Hill, 22 July 2021
Important information about open vials of Accu‑Chek® Aviva / Accu‑Chek® Performa test strips.
Dear valued Accu‑Chek customer,
At Roche Diabetes Care, we strive for the highest quality of products and services and are committed to keeping you informed as soon as there is a potential issue of which you should be made aware. This is why we would like to inform you today about the rare occurrence of Accu‑Chek Aviva / Accu‑Chek Performa test strip vials which have opened while still in a sealed carton.
If you have a test strip vial that has opened while still in a sealed carton, you may observe the inability to perform a valid blood glucose measurement on your meter, because an open vial would expose the test strips to humidity which damages the strips and could result in inaccurate results (such as positively biased, or falsely too high, results). Inappropriate therapy decisions based on inaccurate results could lead to adverse health consequences.
Description of situation and rationale giving rise to this corrective measure
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.
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 Aviva / 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 the 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.
The potentially affected test strips are
The potentially affected test strips are:
Accu‑Chek Aviva
Accu‑Chek Performa
Roche Diabetes Care is updating product labelling 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.
Actions to be taken by users of Accu‑Chek Aviva / Accu‑Chek Performa test strips
Users are advised to always inspect vials of Accu‑Chek Aviva / Accu‑Chek Performa test strips before use.
Please, do not use the test strips if
vial is open or damaged before using the test strips for the first time,
the cap is not fully closed,
you see any damage to the cap or vial, or
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 our Roche Diabetes Care Customer Careline* on 0800 701 000.
