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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64111

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 15, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Viterion TeleHealthcare Llc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

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.

Z-0820-2013
Recall number
Z-0820-2013
Initiated
November 15, 2012
Classification
Class II
Status
Terminated
Quantity
Domestic: 19,106 units; Foreign: 267 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

All units are affected. List of affected serial numbers were provided as Excel spreadsheet due to the large volume.

Distribution pattern

Worldwide Distribution-USA (nationwide) and the United Kingdom.

device · product 2 of 3

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.

Z-0821-2013
Recall number
Z-0821-2013
Initiated
November 15, 2012
Classification
Class II
Status
Terminated
Quantity
Domestic - 7698 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

All units are affected. List of affected serial numbers were provided as Excel spreadsheet due to the large volume.

Distribution pattern

Worldwide Distribution-USA (nationwide) and the United Kingdom.

device · product 3 of 3

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.

Z-0822-2013
Recall number
Z-0822-2013
Initiated
November 15, 2012
Classification
Class II
Status
Terminated
Quantity
Domestic - 296 units, Foreign - 73 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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, A3310HA000221, A3310HA000222, A3310HA000223, A3310HA000224, A3310HA000225, A3404HA000226, A3404HA000227, A3404HA000228, A3404HA000229, A3404HA000230, A3404HA000231, A3404HA000232, A3404HA000233, A3404HA000234, A3404HA000235, A3404HA000236, A3404HA000237, A3404HA000238, A3404HA000239, A3404HA000240, A3404HA000241, A3404HA000242, A3404HA000243, A3404HA000244, A3404HA000245, A3404HA000246, A3404HA000247, A3404HA000248, A3404HA000249, A3404HA000250, A3602HA000252, A3602HA000253, A3602HA000254, A3602HA000255, A3602HA000256, A3602HA000257, A3602HA000258, A3602HA000259, A3602HA000260, A3602HA000261, A3602HA000262, A3602HA000263, A3602HA000264, A3602HA000265, A3602HA000266, A3701HA000267, A3701HA000268, A3701HA000269, A3701HA000270, A3701HA000271, A3701HA000272, A3701HA000273, A3701HA000274, A3701HA000275, A3701HA000276, A3701HA000277, A3701HA000278, A3701HA000279, A3701HA000280, A3701HA000281, A3701HA000282, A3701HA000283, A3701HA000284, A3701HA000285, A3701HA000286, A3701HA000287, A3701HA000288, A3701HA000289, A3701HA000290, A3701HA000291, A3818HA000292, A3818HA000293, A3818HA000294, A3818HA000295, A3818HA000296, A3818HA000297, A3818HA000298, A3818HA000299, A3818HA000300, A3818HA000301, A3818HA000302, A3818HA000303, A3818HA000304, A3818HA000305, A3818HA000306, A3818HA000307, A3818HA000308, A3818HA000309, A3818HA000310, A3818HA000311, A3818HA000312, A3818HA000313, A3818HA000314, A3818HA000315, A3818HA000316, A3905HA000317, A3905HA000318, A3905HA000319, A3905HA000320, A3905HA000321, A3905HA000322, A3905HA000323, A3905HA000324, A3905HA000325, A3905HA000326, A3905HA000327, A3905HA000328, A3905HA000329, A3905HA000330, A3905HA000331, A3905HA000332, A3905HA000333, A3905HA000334, A3905HA000335, A3905HA000336, A3905HA000337, A3905HA000338, A3905HA000339, A3905HA000340, A3905HA000341, A3D01HA000342, A3D01HA000343, A3D01HA000344, A3D01HA000345, A3D01HA000346, A3D01HA000347, A3D01HA000348, A3D01HA000349, A3D01HA000350, A3D01HA000351, A3D01HA000352, A3D01HA000353, A3D01HA000354, A3D01HA000355, A3D01HA000356, A3D01HA000357, A3D01HA000358, A3D01HA000359, A3D01HA000360, A3D01HA000361, A3D01HA000362, A3D01HA000363, A3D01HA000364, A3D01HA000365, A3D01HA000366, A3D01HA000367, A3D01HA000368, A3D01HA000369, A3D01HA000370, A3D01HA000371, A3D01HA000372, A3D01HA000373, A3D01HA000374, A3D01HA000375, A3D01HA000376, A3D01HA000377, A3D01HA000378, A3D01HA000379, A3D01HA000380, A3D01HA000381, A3D01HA000382, A3D01HA000383, A3D01HA000384, A3D01HA000385, A3D01HA000386, A3D01HA000387, A3D01HA000388, A3D01HA000389, A3D01HA000390, A4113HA000391, A4113HA000392, A4113HA000393, A4113HA000394, A4113HA000395, A4113HA000396, A4113HA000397, A4113HA000398, A4113HA000399, A4113HA000400, A4113HA000401, A4113HA000402, A4113HA000403, A4113HA000404, A4113HA000405, A4113HA000406, A4113HA000407, A4113HA000408, A4113HA000409, A4113HA000410, A4113HA000411, A4113HA000412, A4113HA000413, A4113HA000414, A4113HA000415, A4113HA000416, A4113HA000417, A4113HA000418, A4113HA000419, A4113HA000420, A4113HA000421, A4113HA000422, A4113HA000423, A4113HA000424, A4113HA000425, A4113HA000426, A4113HA000427, A4113HA000428, A4113HA000429, A4113HA000430, A4113HA000431, A4113HA000432, A4113HA000433, A4113HA000434, A4113HA000435, A4113HA000436, A4113HA000437, A4113HA000438, A4113HA000439, A4113HA000440, A4113HA000441, A4526MA000442, A4526MA000443, A4526MA000444, A4526MA000446, A4712MA000445, A4712MA000447, A4712MA000448, A4712MA000449, A4712MA000450, A4712MA000451, A4712MA000452, A4712MA000453, A4712MA000454, A4712MA000455, A4712MA000456, A4712MA000457, A4712MA000458, A4712MA000459, A4712MA000460, A4712MA000461, A4712MA000462, A4712MA000463, A4712MA000464, A4712MA000465, A4712MA000466, A4712MA000467, A4712MA000468, A4712MA000469, A4712MA000470, A4712MA000471, A4712MA000472, A4712MA000473, A4712MA000474, A4712MA000475, A4712MA000476, A4712MA000477, A4712MA000478, A4712MA000479, A4712MA000480, A4712MA000481, A4712MA000482, A4712MA000483, A4712MA000484, A4712MA000485, A4712MA000486, A4712MA000487, A4712MA000488, A4712MA000489, A4712MA000490, A4712MA000491, A4712MA000492, A4712MA000493, A4712MA000494, A4712MA000495, A4712MA000496, A4712MA000497, A4712MA000498, A4712MA000499, A4712MA000500, A4712MA000501, A4712MA000502, A4712MA000503, A4712MA000504, A4712MA000505, A4712MA000506, A5225MA000507, A5225MA000508, A5225MA000509, A5225MA000510, A5225MA000511, A5225MA000512, A5225MA000513, A5225MA000514, A5225MA000515, A5225MA000516, A5225MA000517, A5225MA000518, A5225MA000519, A5225MA000520, A5225MA000521, A5225MA000522, A5225MA000523, A5225MA000524, A5225MA000525, A5225MA000526, A5225MA000527, A5225MA000528, A5225MA000529, A5225MA000530, A5225MA000531, A5225MA000532, A5225MA000533, A5225MA000534, A5225MA000535, A5225MA000536, A5225MA000537, A5225MA000538, A5225MA000539, A5225MA000540, A5225MA000541, A5225MA000542, A5225MA000543, A5225MA000544, A5225MA000545, A5225MA000546, A5225MA000547, A5225MA000548, A5225MA000549, A5225MA000550, A5225MA000551, A5225MA000552, A5225MA000553, A5225MA000554, A5225MA000555, A5225MA000556, A5225MA000557, A5225MA000558, A5225MA000559, A5225MA000560, A5225MA000561, A5225MA000562, A5225MA000563, A5225MA000564, A5225MA000565, A5225MA000566, A5225MA000567, A5225MA000568, A5225MA000569, A5225MA000570, A5225MA000571, A5225MA000572, A5225MA000573, A5225MA000574, A5225MA000575, A5225MA000576, A5225MA000577, A5225MA000578, A5225MA000579, A5225MA000580, A5225MA000581, A5225MA000582, A5225MA000583, A5225MA000584, A5225MA000585, A5225MA000586, A5225MA000587, A5225MA000588, A5225MA000589, A5225MA000590 A5225MA000591, A5225MA000592, A5225MA000593, A5225MA000594, A5225MA000595, A5225MA000596, A5225MA000597, A5225MA000598, A5225MA000599, A5225MA000600, A5225MA000601, A5225MA000602, A5225MA000603, A5225MA000604, A5225MA000605, A5225MA000606, A5225MA000607, A5225MA000608, A5225MA000609, A5225MA000610, A5225MA000611, A5225MA000612, A5225MA000613, A5225MA000614, A5225MA000615, A5225MA000616, A5225MA000617, A5225MA000618, A5225MA000619, A5225MA000620, A5225MA000621, A5225MA000622, A5225MA000623, A5225MA000624, A5225MA000625, A5225MA000626, A5225MA000627, A5225MA000628, A5225MA000629, A5225MA000630, A5225MA000631, A5225MA000632, A5225MA000633, A5225MA000634, A5225MA000635, A5225MA000636, A5225MA000637, A5225MA000638, A5225MA000639, A5225MA000640, A5225MA000641, A5225MA000642, A5225MA000643, A5225MA000644, A5225MA000645, A5225MA000646, A5225MA000647, A5225MA000648, A5225MA000649, A5225MA000650, A5225MA000651, A5225MA000652, A5225MA000653, A5225MA000654, A5225MA000655, A5225MA000656, A5225MA000657, A5225MA000658, A5225MA000659, A5225MA000660, A5225MA000661, A5225MA000662, A5225MA000663, A5225MA000664, A5225MA000665, A5225MA000666, A5225MA000667, A5225MA000668, A5225MA000669, A5225MA000670, A5225MA000671, A5225MA000672, A5225MA000673, A5225MA000674, A5225MA000675, A5225MA000676, A5225MA000677, A5225MA000678, A5225MA000679, A5225MA000680, A5225MA000681, A5225MA000682, A5225MA000683, A5225MA000684, A5225MA000685, A5225MA000686, A5225MA000687, A5225MA000688, A5225MA000689, A5225MA000690, A5225MA000691, A5225MA000692, A5225MA000693, A5225MA000694, A5225MA000695, A5225MA000696, A5225MA000697, A5225MA000698, A5225MA000699, A5225MA000700, A5225MA000701, A5225MA000702, A5225MA000703, A5225MA000704, A5225MA000705, A5225MA000706, A5225MA000707, A5225MA000708, A5225MA000709, A5225MA000710, A5225MA000711, A5225MA000712, A5225MA000713, A5225MA000714, A5225MA000715, A5225MA000716, A5225MA000717, A5225MA000718, A5225MA000719, A5225MA000720, A5225MA000721, A5225MA000722, A5225MA000723, A5225MA000724, A5225MA000725, A5225MA000726, A5225MA000727, A5225MA000728, A5225MA000729, A5225MA000730, A5225MA000731, A5225MA000732, A5225MA000733, A5225MA000734, A5311MA000735, A5311MA000736, A5314MA000737, A5314MA000738, A5314MA000739, A5314MA000740, A5314MA000741, A5314MA000742, A5314MA000743, A5314MA000744, A5314MA000745, A5314MA000746, A5314MA000747, A5314MA000748, A5314MA000749, A5314MA000750, A5314MA000751, A5314MA000752, A5314MA000753, A5314MA000754, A5314MA000755, A5314MA000756, A5314MA000757, A5314MA000758, A5314MA000759, A5314MA000760, A5314MA000761, A5414MA000762, A5414MA000763, A5414MA000764, A5414MA000765, A5414MA000766, A5414MA000767, A5414MA000768, A5414MA000769, A5414MA000770, A5414MA000771, A5414MA000772, A5414MA000773, A5414MA000774, A5414MA000775, A5414MA000776, A5414MA000777, A5414MA000778, A5414MA000779, A5414MA000780, A5414MA000781, A5414MA000782, A5414MA000783, A5414MA000784, A5414MA000785, A5414MA000786, A5414MA000787, A5414MA000788, A5414MA000789, A5414MA000790, A5414MA000791, A5414MA000792, A5414MA000793, A5414MA000794, A5414MA000795, A5414MA000796, A5414MA000797, A5414MA000798, A5414MA000799, A5414MA000800, A5414MA000801, A5421MA000802, A5421MA000803, A5421MA000804, A5421MA000805, A5421MA000806, A5421MA000807, A5421MA000808, A5421MA000809, A5421MA000810, A5516MA000811, A5516MA000812, A5516MA000813, A5516MA000814, A5516MA000815, A5516MA000816, A5516MA000817, A5516MA000818, A5516MA000819, A5516MA000820, A5527MA000821, A5527MA000822, A5527MA000823, A5527MA000824, A5527MA000825, A5527MA000826, A5527MA000827, A5527MA000828, A5527MA000829, A5527MA000830, A5527MA000831, A5527MA000832, A5527MA000833, A5527MA000834, A5527MA000835, A5527MA000836, A5527MA000837, A5527MA000838, A5527MA000839, A5527MA000840, A5527MA000841, A5527MA000842, A5527MA000843, A5527MA000844, A5527MA000845, A5527MA000846, A5527MA000847, A5527MA000848, A5527MA000849, A5527MA000850, A5527MA000851, A5527MA000852, A5527MA000853, A5527MA000854, A5527MA000855, A5527MA000856, A5527MA000857, A5527MA000858, A5527MA000859, A5527MA000860, A5D15MA000891, A5D15MA000892, A5D15MA000893, A5D15MA000894, A5D15MA000895, A5D15MA000896, A5D15MA000897, A5D15MA000898, A5D15MA000899, A5D15MA000900, A5D15MA000901, A5D15MA000902, A5D15MA000903, A5D15MA000904, A5D15MA000905, A5D15MA000906, A5D15MA000907, A5D15MA000908, A5D15MA000909, A5D15MA000910, A5D15MA000911, A5D15MA000912, A5D15MA000913, A5D15MA000914, A5D15MA000915, A5D15MA000916, A5D15MA000917, A5D15MA000918, A5D15MA000919, A5D15MA000920, A5N08MA000861, A5N08MA000862, A5N08MA000863, A5N08MA000864, A5N08MA000865, A5N08MA000866, A5N08MA000867, A5N08MA000868, A5N08MA000869, A5N08MA000870, A5N08MA000871, A5N08MA000872, A5N08MA000873, A5N08MA000874, A5N08MA000875, A5N08MA000876, A5N08MA000877, A5N08MA000878, A5N08MA000879, A5N08MA000880, A5N08MA000881, A5N08MA000882, A5N08MA000883, A5N08MA000884, A5N08MA000885, A5N08MA000886, A5N08MA000887, A5N08MA000888, A5N08MA000889, A5N08MA000890, A6112MA000921, A6112MA000922, A6112MA000923, A6112MA000924, A6112MA000925, A6112MA000926, A6112MA000927, A6112MA000928, A6112MA000929, A6112MA000930, A6112MA000931, A6112MA000932, A6112MA000933, A6112MA000934, A6112MA000935, A6112MA000936, A6112MA000937, A6112MA000938, A6112MA000939, A6112MA000940, A6112MA000941, A6112MA000942, A6112MA000943, A6112MA000944, A6112MA000945, A6112MA000946, A6112MA000947, A6112MA000948, A6112MA000949, A6112MA000950, A6824MA000951, A6824MA000952, A6824MA000953, A6824MA000954, A6824MA000955, A6824MA000956, A6824MA000957, A6824MA000958, A6824MA000959, A6824MA000960

Distribution pattern

Worldwide Distribution-USA (nationwide) and the United Kingdom.