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Medication Safety Alerts

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

May 7, 2018

On May 7, 2018, Roche Diabetes issued a medical device correction of ACCU-CHEK® Aviva Plus Test Strips. This medical device correction was issued because the affected strips may have an increased number of:

  • strip errors prior to applying a blood sample, or
  • strips not detected once inserted or
  • wrong results.

This may represent a potential health hazard or safety risk to plan members who may be using product affected by this medical device correction.

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

To see if you have affected product, please check the lot number. The lot number is on the top flap of the manufacturer’s box and on the label on the test strip vial. An example of the location of the lot number is provided here:

If your product is not from one of the affected lot numbers, it is not affected by this correction. If your product is from one of these affected lot numbers, stop using and contact Roche Diabetes Care to get replacement product using one of the following options:

  • E-mail Accu-Chek Customer Care at accu-chek.care@roche.com and include your name, full mailing address, phone number, test strip lot number and number of affected test strips.
  • Call Accu-Chek Customer Care toll-free at 1-800-358-4866, Monday through Friday, 8:00 am to 8:00 pm (ET).

There is no need to return affected products to CVS Caremark.  Roche Diabetes Care will be providing replacement product directly. Once you have received your replacement test strips, any test strips affected by this issue may be thrown away.

You should not continue to use product that is affected by this recall. Please call your doctor right away for advice if you may be using affected product. Your doctor is familiar with your medical history and can suggest the best treatment option for you. If you need a prescription for a different medicine, please call your doctor.

CVS Caremark Response: If you are currently using ACCU-CHEK Aviva Plus Test Strips, please call a Customer Care representative toll-free at 1-866-823-5184 for more information.

If you are currently using ACCU-CHEK Aviva Plus Test Strips and have questions regarding this recall, please call your doctor or please call 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 United States Food and Drug Administration (FDA) consumer inquiry line toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit www.fda.gov.

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