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ACCU-CHEK GUIDE

Model 10436271001 · Roche Diagnostics Operations, Inc. · DI 00365702703209

NBW — System, Test, Blood Glucose, Over The Counter · 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 (2)

InitiatedRecall #ClassStatusReasonLink basis
2024-05-13Z-2174-2024Class IIOpen, ClassifiedThe reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg/dL) and may result in the wrong unit of measure. Which may subsequently cause an error in interpreting a result as approximately 18 times lower that the actual blood glucose. Potential immediate health consequences of the glucose meter providing a reading in the wrong units of measurement (UOM) may result in inappropriate rescue therapy for presumed hypoglycemia including urgent and repeat administration of carbohydrates. This in turn could lead to frequent episodes of hyperglycemia which is unrecognized and undertreated.Long range consequences of continued use of the affected meters could include mismanagement of the patient s diabetes for longer periods of time potentially resulting in a major health event (in general persistent and/or severe hyperglycemia) that may lead them to seek medical attention, and depending on the duration of hyperglycemia, could contribute to the development of microvascular (i.e., retinopathy, neuropathy, nephropathy) and/or macrovascular (i.e., myocardial infarction, ischemic stroke) complications of diabetes and could lead to fetal damage (abnormal fetal growth and altered organ development and maturation, fetal hypoxemia, spontaneous abortion, and congenital anomalies) in pregnant women. This issue was identified by three initial consumer complaints, with reports that the meters were presenting the incorrect unit of measure.k number procode
2019-09-30Z-0747-2020Class IITerminatedPotential power issues with the Accu-Chek Guide Blood Glucose Monitoring System.k number procode

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.

91827372019-01: 0 reports for this device; peer average 14.01/device2019-02: 0 reports for this device; peer average 19.34/device2019-03: 0 reports for this device; peer average 21.77/device2019-04: 0 reports for this device; peer average 28.26/device2019-05: 0 reports for this device; peer average 26.14/device2019-06: 0 reports for this device; peer average 24.19/device2019-07: 0 reports for this device; peer average 24.82/device2019-08: 0 reports for this device; peer average 22.58/device2019-09: 0 reports for this device; peer average 20.42/device2019-10: 0 reports for this device; peer average 22.67/device2019-11: 0 reports for this device; peer average 16.37/device2019-12: 0 reports for this device; peer average 19.89/device2020-01: 0 reports for this device; peer average 22.19/device2020-02: 0 reports for this device; peer average 18.44/device2020-03: 0 reports for this device; peer average 20.57/device2020-04: 0 reports for this device; peer average 17.63/device2020-05: 0 reports for this device; peer average 24.77/device2020-06: 0 reports for this device; peer average 30.27/device2020-07: 0 reports for this device; peer average 18.51/device2020-08: 0 reports for this device; peer average 12.33/device2020-09: 0 reports for this device; peer average 19.58/device2020-10: 0 reports for this device; peer average 12.45/device2020-11: 0 reports for this device; peer average 18.13/device2020-12: 0 reports for this device; peer average 18.98/device2021-01: 0 reports for this device; peer average 16.35/device2021-02: 0 reports for this device; peer average 17.07/device2021-03: 0 reports for this device; peer average 18.21/device2021-04: 0 reports for this device; peer average 19.62/device2021-05: 0 reports for this device; peer average 20/device2021-06: 0 reports for this device; peer average 19.7/device2021-07: 0 reports for this device; peer average 28.06/device2021-08: 0 reports for this device; peer average 17.13/device2021-09: 0 reports for this device; peer average 21.17/device2021-10: 0 reports for this device; peer average 19.14/device2021-11: 0 reports for this device; peer average 16.63/device2021-12: 0 reports for this device; peer average 23.6/device2022-01: 0 reports for this device; peer average 16.23/device2022-02: 0 reports for this device; peer average 15.33/device2022-03: 0 reports for this device; peer average 17.98/device2022-04: 0 reports for this device; peer average 16.62/device2022-05: 0 reports for this device; peer average 18.6/device2022-06: 0 reports for this device; peer average 14.8/device2022-07: 0 reports for this device; peer average 14.55/device2022-08: 0 reports for this device; peer average 8/device2022-09: 0 reports for this device; peer average 9.32/device2022-10: 0 reports for this device; peer average 8.08/device2022-11: 0 reports for this device; peer average 11.65/device2022-12: 0 reports for this device; peer average 7.24/device2023-01: 0 reports for this device; peer average 13.11/device2023-02: 0 reports for this device; peer average 9.6/device2023-03: 0 reports for this device; peer average 9.9/device2023-04: 0 reports for this device; peer average 7.78/device2023-05: 0 reports for this device; peer average 36.62/device2023-06: 0 reports for this device; peer average 23.03/device2023-07: 0 reports for this device; peer average 13.17/device2023-08: 0 reports for this device; peer average 11.24/device2023-09: 0 reports for this device; peer average 6.48/device2023-10: 0 reports for this device; peer average 6.48/device2023-11: 0 reports for this device; peer average 4.73/device2023-12: 0 reports for this device; peer average 4.39/device2024-01: 0 reports for this device; peer average 8.58/device2024-02: 0 reports for this device; peer average 2.73/device2024-03: 0 reports for this device; peer average 7.97/device2024-04: 0 reports for this device; peer average 4.02/device2024-05: 0 reports for this device; peer average 7.3/device2024-06: 0 reports for this device; peer average 5.13/device2024-07: 0 reports for this device; peer average 3.64/device2024-08: 0 reports for this device; peer average 3.3/device2024-09: 0 reports for this device; peer average 3.83/device2024-10: 0 reports for this device; peer average 4.44/device2024-11: 0 reports for this device; peer average 2.81/device2024-12: 0 reports for this device; peer average 5.57/device2025-01: 0 reports for this device; peer average 5.49/device2025-02: 0 reports for this device; peer average 2.66/device2025-03: 0 reports for this device; peer average 2.86/device2025-04: 0 reports for this device; peer average 3.69/device2025-05: 0 reports for this device; peer average 4.88/device2025-06: 0 reports for this device; peer average 3.09/device2025-07: 0 reports for this device; peer average 3.13/device2025-08: 0 reports for this device; peer average 4.73/device2025-09: 0 reports for this device; peer average 2.75/device2025-10: 0 reports for this device; peer average 3.59/device2025-11: 0 reports for this device; peer average 3.6/device2025-12: 0 reports for this device; peer average 2.64/device2026-01: 0 reports for this device; peer average 4.2/device2026-02: 0 reports for this device; peer average 2.35/device2026-03: 0 reports for this device; peer average 3.51/device2026-04: 0 reports for this device; peer average 3.03/device2026-05: 0 reports for this device; peer average 3.02/device2026-06: 0 reports for this device; peer average 4.17/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-01014.01
2019-02019.34
2019-03021.77
2019-04028.26
2019-05026.14
2019-06024.19
2019-07024.82
2019-08022.58
2019-09020.42
2019-10022.67
2019-11016.37
2019-12019.89
2020-01022.19
2020-02018.44
2020-03020.57
2020-04017.63
2020-05024.77
2020-06030.27
2020-07018.51
2020-08012.33
2020-09019.58
2020-10012.45
2020-11018.13
2020-12018.98
2021-01016.35
2021-02017.07
2021-03018.21
2021-04019.62
2021-05020
2021-06019.7
2021-07028.06
2021-08017.13
2021-09021.17
2021-10019.14
2021-11016.63
2021-12023.6
2022-01016.23
2022-02015.33
2022-03017.98
2022-04016.62
2022-05018.6
2022-06014.8
2022-07014.55
2022-0808
2022-0909.32
2022-1008.08
2022-11011.65
2022-1207.24
2023-01013.11
2023-0209.6
2023-0309.9
2023-0407.78
2023-05036.62
2023-06023.03
2023-07013.17
2023-08011.24
2023-0906.48
2023-1006.48
2023-1104.73
2023-1204.39
2024-0108.58
2024-0202.73
2024-0307.97
2024-0404.02
2024-0507.3
2024-0605.13
2024-0703.64
2024-0803.3
2024-0903.83
2024-1004.44
2024-1102.81
2024-1205.57
2025-0105.49
2025-0202.66
2025-0302.86
2025-0403.69
2025-0504.88
2025-0603.09
2025-0703.13
2025-0804.73
2025-0902.75
2025-1003.59
2025-1103.6
2025-1202.64
2026-0104.2
2026-0202.35
2026-0303.51
2026-0403.03
2026-0503.02
2026-0604.17
This device (reports/month)Average device in NBW (reports/device/month)

Regulatory clearances

  • K160944 SESE 2016-08-31 (k number procode)

Predicate lineage

K160944 — cited as predicate by K203711, K213131

Lineage extracted from public 510(k) summary text (heuristic).

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