The Livongo Health In Touch¿ Blood Glucose Monitoring recall
The Livongo Health In Touch¿ Blood Glucose Monitoring System (BGMS), is an Over-The-Counter (OTC) system designed for the self- monitoring of blood…
Why was The Livongo Health In Touch¿ Blood Glucose Monitoring recalled?
The instructional insert for the In Touch Control Solution for use with the In Touch meter and In Touch strips as a quality control check did not contain the limitation of sensor accuracy: (1) with the use of acetaminophen (Tylenol) (2) with the use of Ascorbic Acid (vitamin C) supplementation (3) in the presence of uric acid
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?
Model/Reorder Number 3614-001-001 with the following lot numbers 890071 890072, 890073, 890074, 890075, 890076, 890077, 890078 and 890079.
- Product
- The Livongo Health In Touch¿ Blood Glucose Monitoring System (BGMS), is an Over-The-Counter (OTC) system designed for the self- monitoring of blood…
- Recalling firm
- Livongo Health
- Quantity
- 63,000 units
- Distribution
- US consignees: Arizona, California, Delaware, Florida, Georgia, Illinois, Kentucky, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington.
- Recall date
- May 11, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)