The Recall Desk

FDA (Devices) recall action 64111

Viterion TeleHealthcare Llc recalled 3 products on 2013-02-20

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2013-02-20
Critical
0
Units
7,698

Why these products were recalled

Viterion telehealth monitors do not transmit "HI" (above the meter's measurable range) and "LO" (below the meter's measurable range) blood glucose readings from Bayer's Contour Elite XL blood glucose meters, or from Roche's Accu-Chek Advantage 03 and 04 meters to healthcare professionals.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • HighFDA (Devices)··2013-02-20

    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.

    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.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-02-20

    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.

    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.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-02-20

    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.

    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.
    Category
    Distribution
    0 states