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ACCU-CHEK AVIVA PLUS

Model 06908420002 · Roche Diagnostics Operations, Inc. · DI 00365702700932

LFR — Glucose Dehydrogenase, Glucose · Class II · 21 CFR 862.1345

UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

3710132019-01: 0 reports for this device; peer average 8.87/device2019-02: 0 reports for this device; peer average 10/device2019-03: 0 reports for this device; peer average 9.14/device2019-04: 0 reports for this device; peer average 13.35/device2019-05: 0 reports for this device; peer average 11.61/device2019-06: 0 reports for this device; peer average 11.16/device2019-07: 0 reports for this device; peer average 11.37/device2019-08: 0 reports for this device; peer average 11.23/device2019-09: 0 reports for this device; peer average 9.05/device2019-10: 0 reports for this device; peer average 9.22/device2019-11: 0 reports for this device; peer average 7.09/device2019-12: 0 reports for this device; peer average 5.97/device2020-01: 0 reports for this device; peer average 8.74/device2020-02: 0 reports for this device; peer average 7.36/device2020-03: 0 reports for this device; peer average 7.88/device2020-04: 0 reports for this device; peer average 7.33/device2020-05: 0 reports for this device; peer average 8.65/device2020-06: 0 reports for this device; peer average 8.05/device2020-07: 0 reports for this device; peer average 6.97/device2020-08: 0 reports for this device; peer average 4.44/device2020-09: 0 reports for this device; peer average 9.55/device2020-10: 0 reports for this device; peer average 5.03/device2020-11: 0 reports for this device; peer average 7.15/device2020-12: 0 reports for this device; peer average 7.11/device2021-01: 0 reports for this device; peer average 9.11/device2021-02: 0 reports for this device; peer average 7.95/device2021-03: 0 reports for this device; peer average 7.12/device2021-04: 0 reports for this device; peer average 8.16/device2021-05: 0 reports for this device; peer average 5.87/device2021-06: 0 reports for this device; peer average 7.26/device2021-07: 0 reports for this device; peer average 8.31/device2021-08: 0 reports for this device; peer average 8.96/device2021-09: 0 reports for this device; peer average 8.24/device2021-10: 0 reports for this device; peer average 8.24/device2021-11: 0 reports for this device; peer average 8.87/device2021-12: 0 reports for this device; peer average 9.97/device2022-01: 0 reports for this device; peer average 8.46/device2022-02: 0 reports for this device; peer average 7.61/device2022-03: 0 reports for this device; peer average 9.07/device2022-04: 0 reports for this device; peer average 8.69/device2022-05: 0 reports for this device; peer average 7.15/device2022-06: 0 reports for this device; peer average 6.51/device2022-07: 0 reports for this device; peer average 7.8/device2022-08: 0 reports for this device; peer average 3.58/device2022-09: 0 reports for this device; peer average 4.01/device2022-10: 0 reports for this device; peer average 3.88/device2022-11: 0 reports for this device; peer average 8.03/device2022-12: 0 reports for this device; peer average 3.85/device2023-01: 0 reports for this device; peer average 6.97/device2023-02: 0 reports for this device; peer average 5.46/device2023-03: 0 reports for this device; peer average 4.71/device2023-04: 0 reports for this device; peer average 2.97/device2023-05: 0 reports for this device; peer average 4.28/device2023-06: 0 reports for this device; peer average 3.85/device2023-07: 0 reports for this device; peer average 3.28/device2023-08: 0 reports for this device; peer average 4.91/device2023-09: 0 reports for this device; peer average 2.62/device2023-10: 0 reports for this device; peer average 2.92/device2023-11: 0 reports for this device; peer average 2.86/device2023-12: 0 reports for this device; peer average 2.54/device2024-01: 0 reports for this device; peer average 5.41/device2024-02: 0 reports for this device; peer average 2.44/device2024-03: 0 reports for this device; peer average 5.41/device2024-04: 0 reports for this device; peer average 3.01/device2024-05: 0 reports for this device; peer average 4.45/device2024-06: 0 reports for this device; peer average 3.52/device2024-07: 0 reports for this device; peer average 2.43/device2024-08: 0 reports for this device; peer average 2.34/device2024-09: 0 reports for this device; peer average 2.97/device2024-10: 0 reports for this device; peer average 3.97/device2024-11: 0 reports for this device; peer average 2.4/device2024-12: 0 reports for this device; peer average 4.28/device2025-01: 0 reports for this device; peer average 5.77/device2025-02: 0 reports for this device; peer average 2.22/device2025-03: 0 reports for this device; peer average 2.47/device2025-04: 0 reports for this device; peer average 4.3/device2025-05: 0 reports for this device; peer average 5.09/device2025-06: 0 reports for this device; peer average 2.26/device2025-07: 0 reports for this device; peer average 2.06/device2025-08: 0 reports for this device; peer average 4.08/device2025-09: 0 reports for this device; peer average 2.55/device2025-10: 0 reports for this device; peer average 3.37/device2025-11: 0 reports for this device; peer average 3.2/device2025-12: 0 reports for this device; peer average 3.83/device2026-01: 0 reports for this device; peer average 4.64/device2026-02: 0 reports for this device; peer average 2.34/device2026-03: 0 reports for this device; peer average 5.13/device2026-04: 0 reports for this device; peer average 5.43/device2026-05: 0 reports for this device; peer average 4.09/device2026-06: 0 reports for this device; peer average 6.93/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0108.87
2019-02010
2019-0309.14
2019-04013.35
2019-05011.61
2019-06011.16
2019-07011.37
2019-08011.23
2019-0909.05
2019-1009.22
2019-1107.09
2019-1205.97
2020-0108.74
2020-0207.36
2020-0307.88
2020-0407.33
2020-0508.65
2020-0608.05
2020-0706.97
2020-0804.44
2020-0909.55
2020-1005.03
2020-1107.15
2020-1207.11
2021-0109.11
2021-0207.95
2021-0307.12
2021-0408.16
2021-0505.87
2021-0607.26
2021-0708.31
2021-0808.96
2021-0908.24
2021-1008.24
2021-1108.87
2021-1209.97
2022-0108.46
2022-0207.61
2022-0309.07
2022-0408.69
2022-0507.15
2022-0606.51
2022-0707.8
2022-0803.58
2022-0904.01
2022-1003.88
2022-1108.03
2022-1203.85
2023-0106.97
2023-0205.46
2023-0304.71
2023-0402.97
2023-0504.28
2023-0603.85
2023-0703.28
2023-0804.91
2023-0902.62
2023-1002.92
2023-1102.86
2023-1202.54
2024-0105.41
2024-0202.44
2024-0305.41
2024-0403.01
2024-0504.45
2024-0603.52
2024-0702.43
2024-0802.34
2024-0902.97
2024-1003.97
2024-1102.4
2024-1204.28
2025-0105.77
2025-0202.22
2025-0302.47
2025-0404.3
2025-0505.09
2025-0602.26
2025-0702.06
2025-0804.08
2025-0902.55
2025-1003.37
2025-1103.2
2025-1203.83
2026-0104.64
2026-0202.34
2026-0305.13
2026-0405.43
2026-0504.09
2026-0606.93
This device (reports/month)Average device in LFR (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Roche Diagnostics Operations, Inc.

  • NAI 2023-11-30 Roche Molecular Systems, Inc. · 0 citations
  • NAI 2022-12-07 Roche Diagnostics Operations, Inc. · 0 citations
  • NAI 2022-09-23 Ventana Medical Systems, Inc. · 0 citations
  • NAI 2022-09-15 Ventana Medical Systems, Inc. · 0 citations
  • NAI 2021-07-29 Ventana Medical Systems, Inc. · 0 citations
  • NAI 2020-02-26 Ventana Medical Systems, Inc. · 0 citations
  • VAI 2019-08-29 Roche Diagnostics GmbH · 0 citations
  • NAI 2019-08-14 Ventana Medical Systems, Inc. · 0 citations
  • VAI 2019-07-25 Roche Diabetes Care, Inc. · 3 citations
  • VAI 2019-06-27 Roche Diagnostics Operations, Inc. · 1 citations
  • NAI 2018-04-19 Roche Diagnostics GmbH · 0 citations
  • NAI 2018-04-12 Roche Diagnostics GmbH · 0 citations
  • NAI 2017-07-24 Roche Molecular Systems, Inc. · 0 citations
  • NAI 2017-07-13 Ventana Medical Systems, Inc. · 0 citations
  • NAI 2017-02-27 Roche Molecular Systems, Inc. · 0 citations
  • VAI 2017-02-02 Roche Diabetes Care GmbH · 1 citations
  • NAI 2016-11-18 Roche Diagnostics GmbH · 0 citations
  • NAI 2016-10-14 Roche Diagnostics Operations, Inc. · 0 citations
  • NAI 2016-09-01 Roche Molecular Systems, Inc. · 0 citations
  • VAI 2016-08-15 Roche Diagnostics Operations, Inc. · 1 citations