Drug Safety Alerts

ACCU-CHEK® Aviva Plus Test Strips Urgent Medical Device Correction

5/07/18

On May 7, 2018, Roche Diabetes issued a consumer-level medical device correction of ACCU-CHEK^® Aviva Plus Test Strips. This medical device correction was issued because four test strip lots were identified as being out of specification during ongoing quality monitoring and marketing surveillance processes. Affected test strips show an increased potential for:

• strip errors prior to applying a blood sample, or

• strips not detected once inserted or,

• in a very limited number of cases, an inaccurate result may occur which may not be detectable.

It was found that the affected strips had cracked reagent, which may lead to these issues.

A complete list of the affected products and lot numbers is provided here:

CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy is contacting patients and prescribers to advise them of this recall. We are encouraging patients who are using ACCU-CHEK Aviva Plus Test Strips to contact their prescriber.

For more information about this issue, health care providers may contact Accu-Chek Customer Care 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 contact the U.S. Food and Drug Administration at 1‑888‑INFO-FDA (1‑888‑463‑6332) or visit www.fda.gov.