Drug Safety Alerts

Accu-Chek® Aviva Plus test strips

12/11/2019

On December 11, 2019, Roche Diabetes Care issued a consumer-level medical device correction of Accu-Chek® Aviva Plus test strips. This medical device correction was issued because Roche Diabetes Care received customer feedback related to specific lots of the Accu-Chek Aviva Plus test strips which could not be dosed as intended. Consumers may experience this as blood application not detected, test strip defective, E-4 + Drop symbol flashing, M-54, and E-54 errors.

A list of the affected products is provided here:

The Accu-Chek Aviva Plus test strips consist 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.

Please note that the affected test strips will not produce inaccurate results due to this issue.

Inability to dose the Accu-Chek Aviva Plus test strips may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions. Such a failure could cause a delay in therapy decisions that may potentially contribute to health effects requiring assistance to resolve.

This could be a health hazard or safety risk to patients who may be using product affected by this recall.

CVS Caremark Response: Because of this action, CVS Caremark® is sending letters to members who received this product through CVS Caremark® Mail Service Pharmacy and their physicians.

For more information about this recall, please contact Accu-Chek Customer Care toll-free at 1‑800-358-4866, Monday through Friday, 8:00 am to 8:00 pm (ET) or visit www.accu-chek.com. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov/.