Viterion TeleHealth Monitors Fail to Transmit Out-of-Range Blood Glucose Readings
Viterion TeleHealth Monitors are being recalled because they do not transmit 'HI' or 'LO' 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. The hazard involves the failure to transmit critical out-of-range medical data, which poses a risk of harm to patients if healthcare professionals are unaware of extreme glucose levels, but no injuries or deaths are reported in the source text.
Plain-English summary
Viterion TeleHealthcare LLC is recalling Viterion TeleHealth Monitors, including the V500 model (Product Codes 08832984 and 02080468) and V100/V100-BGM models. The recall involves 296 domestic units and 73 foreign units distributed in the United States and the United Kingdom.
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 and Roche's Accu-Chek Advantage 03 and 04 meters, preventing these specific out-of-range values from being sent to healthcare professionals.
All units are affected. Consumers and healthcare providers should check their serial numbers against the list provided in the official recall notice. If a unit is affected, it should be removed from service and returned to the manufacturer for repair or replacement.
The recalled product
- Product
- Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) - Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
- Manufacturer
- Viterion TeleHealthcare Llc
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 (20)
- All units are affected. Serial Numbers A3303HA000201
- A3303HA000202
- A3303HA000203
- A3303HA000204
- A3303HA000205
- A3304HA000206
- A3304HA000207
- A3304HA000208
- A3304HA000209
- A3304HA000210
- A3305HA000211
- A3305HA000212
- A3305HA000213
- A3305HA000214
- A3305HA000215
- A3306HA000216
- A3306HA000217
- A3306HA000218
- A3306HA000219
- A3306HA000220
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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