Livongo Health Recalls In Touch Blood Glucose Monitoring System Inserts
Livongo Health is recalling 63,000 units of the In Touch Blood Glucose Monitoring System because the instructional insert omitted specific sensor accuracy limitations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a labeling omission regarding sensor accuracy limitations rather than a direct physical defect or reported injury, fitting the criteria for moderate severity.
Plain-English summary
Livongo Health is recalling 63,000 units of the In Touch Blood Glucose Monitoring System (BGMS). The recall involves Model/Reorder Number 3614-001-001 with lot numbers 890071 through 890079. The product is an over-the-counter system designed for self-monitoring of blood glucose by persons with diabetes in home settings.
The recall was initiated because the instructional insert for the In Touch Control Solution did not contain the limitation of sensor accuracy. Specifically, the insert failed to note that sensor accuracy is limited with the use of acetaminophen (Tylenol), with the use of Ascorbic Acid (vitamin C) supplementation, and in the presence of uric acid.
The affected units were distributed to consignees in 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. Consumers should check their lot numbers and contact the manufacturer for instructions.
The recalled product
- 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 glucose by persons with diabetes in home settings to aid in their diabetes management.
- Manufacturer
- Livongo Health
- Affected units
- 63,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Model/Reorder Number 3614-001-001 with the following lot numbers 890071 890072
- 890073
- 890074
- 890075
- 890076
- 890077
- 890078 and 890079.
Distribution
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