Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Android App Software versions 4.3.0-4.3.2
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
LABSTYLE INNOVATIONS
Reason for Recall:
The Dario-Blood Glucose Tracker Android App versions 4.3.0-4.3.2 may experience duplicate logging of a blood glucose level reading.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2

Product Codes/Lot Numbers:

Android App Software versions 4.3.0-4.3.2

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0260-2020