Dario Blood Glucose Monitoring System recall
Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
Why was Dario Blood Glucose Monitoring System recalled?
The Dario-Blood Glucose Tracker Android App versions 4.3.0-4.3.2 may experience duplicate logging of a blood glucose level reading.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Android App Software versions 4.3.0-4.3.2
- Product
- Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
- Recalling firm
- LABSTYLE INNOVATIONS
- Quantity
- 126,271 (83,141 US; 43,130 OUS)
- Distribution
- Nationwide domestic distribution. Foreign distribution to Australia, Canada, UK, and Italy.
- Recall date
- November 6, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)