Events

Safety Alert for OneTouch Ultra 1x50 Glucose Test Strips

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by N/A.

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
    2014-12-17
  • Event Date Posted
    2014-12-17
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141217.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: onetouch ultra 1x50 glucose test strips the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning onetouch ultra 1x50 test strips distributed by chemilines limited in the united kingdom. the affected batch number is 3621702/001 and the expiry date is oct 2015. the distributor issued a voluntary recall on one batch of onetouch ultra- 1x50 test strips due to an error in the re-packaging process whereby wrong information input in the code box of the primary pack over-label. the primary pack is covering the code on the original manufacturer’s label related to the reading accuracy of the result. that code should be input by the patient into the meter device for reading confirmation. as a result, the patient may experience difficulties using the product for details, please refer to the following link: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con484997 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 december 2014.

Device

OneTouch Ultra 1x50 Glucose Test Strips
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: OneTouch Ultra 1x50 Glucose Test Strips
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    DH