The Therapeutic Goods Administration (TGA), Australia posted a medical device safety alert concerning Accu-Chek Aviva test strips [Catalogue Number: 06453970020; Lot Number: 498287] manufactured by Roche Diabetes Care GmbH.
The manufacturer received customer feedback related to specific lots of the affected product which could not be dosed as intended.
According to the manufacturer, the affected product consists of several material layers. During the manufacturing process, one of these layers was not assembled correctly, resulting in the inability to dose the test strips.
The failure mode does not affect the accuracy of a successfully performed blood glucose measurement.
Customers are advised to discontinue using the strips from the affected lot.
According to the local supplier, the affected products are not distributed in Hong Kong.
For details, please visit the following TGA website:
https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01825-1
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 16 December 2019