Events

Safety Alert for Accu-Chek Performa Nano

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Roche Diabetes Care.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-07-19
  • Event Date Posted
    2016-07-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160719.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: roche accu-chek performa nano 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.

Device

Accu-Chek Performa Nano
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Roche Accu-Chek Performa Nano
  • Manufacturer
    Roche Diabetes Care

Manufacturer

Roche Diabetes Care