Z-0820-2013 Class II Terminated
FDA device recall Z-0820-2013 was initiated by Viterion TeleHealthcare Llc on November 15, 2012 and is designated Class II. Reason for recall: 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 … The recall status is terminated (terminated February 16, 2017). Affected quantity: Domestic: 19,106 units; Foreign: 267 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 20, 2013
- Initiation Date
- November 15, 2012
- Termination Date
- February 16, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Domestic: 19,106 units; Foreign: 267 units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the United Kingdom.
Code Information
All units are affected. List of affected serial numbers were provided as Excel spreadsheet due to the large volume.