The Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom posted a medical device safety alert concerning Accu-Chek Performa Nano manufactured by Roche Diabetes Care. The affected lot numbers are 10135127 and 10134053.
During internal testing, the manufacturer has detected the code key to be missing in 1,200 Accu-Chek Performa Nano kits out of the affected lots. The Accu-Chek Performa Nano blood glucose meter cannot be operated without the pre-inserted code key.
According to the manufacturer, appropriate corrective measures to the production process have been implemented. New Accu-Chek Performa Nano kits will be available shortly.
For details, please refer to the MHRA website:
https://www.gov.uk/drug-device-alerts/field-safety-notices-11-july-15-july-2016
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 July 2016