Viterion TeleHealth Monitors Fail to Transmit Out-of-Range Blood Glucose Readings
Viterion TeleHealth Monitors are being recalled because they do not transmit out-of-range blood glucose readings from specific Bayer and Roche meters to healthcare professionals.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where the failure to transmit critical out-of-range data could lead to delayed medical intervention, though no specific injuries are reported in the source text.
Plain-English summary
Viterion TeleHealthcare LLC is recalling Viterion TeleHealth Monitors, including the V100-BGM model, because they do not transmit "HI" (above the meter's measurable range) and "LO" (below the meter's measurable range) blood glucose readings. This defect affects readings from Bayer's Contur Elite XL blood glucose meters, as well as Roche's Accu-Chek Advantage 03 and 04 meters, preventing these specific out-of-range values from being sent to healthcare professionals.
The recall covers 7,698 units distributed nationwide in the United States and in the United Kingdom. All units are affected by this issue.
Consumers should stop using the affected monitors to transmit blood glucose data and contact Viterion TeleHealthcare LLC for further instructions on how to resolve the issue.
The recalled product
- Product
- Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Physiological patient monitor (without arrhythmia detection or alarms) . Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
- Manufacturer
- Viterion TeleHealthcare Llc
- Affected units
- 7,698
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Viterion TeleHealthcare Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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See all →- HighViterion TeleHealth Monitors Fail to Transmit Out-of-Range Blood Glucose Readings
FDA (Devices) · 2013-02-20
- HighViterion TeleHealth Monitors Fail to Transmit Out-of-Range Blood Glucose Readings
FDA (Devices) · 2013-02-20
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