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ACCU-CHEK Inform II

Model 05213509001 · Roche Diagnostics Operations, Inc. · DI 00365702237100

JJX — Single (Specified) Analyte Controls (Assayed And Unassayed) · Class I · 21 CFR 862.1660

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.

24682019-01: 0 reports for this device; peer average 3.18/device2019-02: 0 reports for this device; peer average 4.33/device2019-03: 0 reports for this device; peer average 3.36/device2019-04: 0 reports for this device; peer average 3.56/device2019-05: 0 reports for this device; peer average 5.7/device2019-06: 0 reports for this device; peer average 7.88/device2019-07: 0 reports for this device; peer average 5.75/device2019-08: 0 reports for this device; peer average 3.45/device2019-09: 0 reports for this device; peer average 3.25/device2019-10: 0 reports for this device; peer average 4.27/device2019-11: 0 reports for this device; peer average 3.23/device2019-12: 0 reports for this device; peer average 3.57/device2020-01: 0 reports for this device; peer average 2.67/device2020-02: 0 reports for this device; peer average 3.67/device2020-03: 0 reports for this device; peer average 3.27/device2020-04: 0 reports for this device; peer average 4.22/device2020-05: 0 reports for this device; peer average 3.27/device2020-06: 0 reports for this device; peer average 4/device2020-07: 0 reports for this device; peer average 4.75/device2020-08: 0 reports for this device; peer average 2.67/device2020-09: 0 reports for this device; peer average 4.38/device2020-10: 0 reports for this device; peer average 3.5/device2020-11: 0 reports for this device; peer average 4.33/device2020-12: 0 reports for this device; peer average 1.83/device2021-01: 0 reports for this device; peer average 3/device2021-02: 0 reports for this device; peer average 2.13/device2021-03: 0 reports for this device; peer average 2.18/device2021-04: 0 reports for this device; peer average 3.22/device2021-05: 0 reports for this device; peer average 3/device2021-06: 0 reports for this device; peer average 2.14/device2021-07: 0 reports for this device; peer average 2.75/device2021-08: 0 reports for this device; peer average 3.43/device2021-09: 0 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 1.2/device2021-11: 0 reports for this device; peer average 2.67/device2021-12: 0 reports for this device; peer average 1.25/device2022-01: 0 reports for this device; peer average 2.33/device2022-02: 0 reports for this device; peer average 2.14/device2022-03: 0 reports for this device; peer average 1.86/device2022-04: 0 reports for this device; peer average 1.75/device2022-05: 0 reports for this device; peer average 1.33/device2022-06: 0 reports for this device; peer average 2.75/device2022-07: 0 reports for this device; peer average 1.6/device2022-08: 0 reports for this device; peer average 1.5/device2022-09: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 1.67/device2022-11: 0 reports for this device; peer average 2.4/device2022-12: 0 reports for this device; peer average 1.8/device2023-01: 0 reports for this device; peer average 1.8/device2023-02: 0 reports for this device; peer average 3.4/device2023-03: 0 reports for this device; peer average 2/device2023-04: 0 reports for this device; peer average 1.25/device2023-05: 0 reports for this device; peer average 2.33/device2023-06: 0 reports for this device; peer average 1.17/device2023-07: 0 reports for this device; peer average 1.33/device2023-08: 0 reports for this device; peer average 2.5/device2023-09: 0 reports for this device; peer average 3/device2023-10: 0 reports for this device; peer average 1.5/device2023-11: 0 reports for this device; peer average 2.33/device2023-12: 0 reports for this device; peer average 1.67/device2024-01: 0 reports for this device; peer average 1.6/device2024-02: 0 reports for this device; peer average 2/device2024-03: 0 reports for this device; peer average 3/device2024-04: 0 reports for this device; peer average 3/device2024-05: 0 reports for this device; peer average 3.67/device2024-06: 0 reports for this device; peer average 1.67/device2024-07: 0 reports for this device; peer average 2.75/device2024-08: 0 reports for this device; peer average 2/device2024-09: 0 reports for this device; peer average 2/device2024-10: 0 reports for this device; peer average 2/device2024-11: 0 reports for this device; peer average 1.67/device2024-12: 0 reports for this device; peer average 4/device2025-01: 0 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 2/device2025-03: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 2/device2025-05: 0 reports for this device; peer average 3/device2025-06: 0 reports for this device; peer average 4.25/device2025-07: 0 reports for this device; peer average 6/device2025-08: 0 reports for this device; peer average 2/device2025-09: 0 reports for this device; peer average 8/device2025-10: 0 reports for this device; peer average 4/device2025-11: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 3/device2026-01: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 3/device2026-04: 0 reports for this device; peer average 3/device2026-06: 0 reports for this device; peer average 3/device01020304050607080910111201020304050607080910111201020304050607080910111201020304050607080910111201020304050607080910111201020304050607080910111201020304050607080910111201020406
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.18
2019-0204.33
2019-0303.36
2019-0403.56
2019-0505.7
2019-0607.88
2019-0705.75
2019-0803.45
2019-0903.25
2019-1004.27
2019-1103.23
2019-1203.57
2020-0102.67
2020-0203.67
2020-0303.27
2020-0404.22
2020-0503.27
2020-0604
2020-0704.75
2020-0802.67
2020-0904.38
2020-1003.5
2020-1104.33
2020-1201.83
2021-0103
2021-0202.13
2021-0302.18
2021-0403.22
2021-0503
2021-0602.14
2021-0702.75
2021-0803.43
2021-0902
2021-1001.2
2021-1102.67
2021-1201.25
2022-0102.33
2022-0202.14
2022-0301.86
2022-0401.75
2022-0501.33
2022-0602.75
2022-0701.6
2022-0801.5
2022-0901
2022-1001.67
2022-1102.4
2022-1201.8
2023-0101.8
2023-0203.4
2023-0302
2023-0401.25
2023-0502.33
2023-0601.17
2023-0701.33
2023-0802.5
2023-0903
2023-1001.5
2023-1102.33
2023-1201.67
2024-0101.6
2024-0202
2024-0303
2024-0403
2024-0503.67
2024-0601.67
2024-0702.75
2024-0802
2024-0902
2024-1002
2024-1101.67
2024-1204
2025-0102
2025-0202
2025-0302
2025-0402
2025-0503
2025-0604.25
2025-0706
2025-0802
2025-0908
2025-1004
2025-1101
2025-1203
2026-0101
2026-0203
2026-0403
2026-0603
This device (reports/month)Average device in JJX (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