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