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FIELD SAFETY NOTICE - ACCU-CHEK AVIVA & ACCU-CHEK PERFORMA

Recalls and Alerts

Field Safety Notice

FIELD SAFETY NOTICE - ACCU-CHEK AVIVA & ACCU-CHEK PERFORMA

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

MHRA drug alert link: N/A  

Pip code

Product description

Supplier

Batch Numbers

3981214

ACCU-CHECK PERFORMA T/STRIPS

ROCHE

ALL STOCK

3171253

ACCU-CHEK AVIVA BLD T/STRIP

ROCHE

ALL STOCK

 

This is a caution in use only we are not accepting stock returns.

 

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 at UK: 0800 701 000* or Ireland: 1 800 709 600*

If you have any questions, then please contact your local Service Centre Customer Services team.