Viterion TeleHealth Monitors Fail to Transmit Out-of-Range Blood Glucose Readings
Viterion TeleHealth Monitors are being recalled because they fail to transmit out-of-range blood glucose readings from specific Bayer and Roche meters to healthcare professionals.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a medical device defect that prevents the transmission of critical out-of-range blood glucose data to healthcare professionals, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Viterion TeleHealthcare LLC is recalling Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). The affected devices are physiological patient monitors that transfer medical information but do not include arrhythmia detection or alarms.
The recall is due to a defect where the monitors do not transmit "HI" (above the meter's measurable range) and "LO" (below the meter's measurable range) blood glucose readings. This failure affects data from Bayer's Contour Elite XL blood glucose meters, as well as Roche's Accu-Chek Advantage 03 and 04 meters, preventing healthcare professionals from receiving these specific out-of-range values.
Approximately 19,106 units were distributed in the United States and 267 units in the United Kingdom. All units are affected. Consumers and healthcare providers should contact Viterion TeleHealthcare LLC for further instructions regarding the recall.
The recalled product
- Product
- Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
- Manufacturer
- Viterion TeleHealthcare Llc
- Category
- Medical Device — Patient Monitor
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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