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ADVIA 2120i Refurb w/o Autosampler

Model 11314046 · Siemens Healthcare Diagnostics Inc. · DI 00630414237909

GKZ — Counter, Differential Cell · Class II · 21 CFR 864.5220

UDILibrary device dossier · generated 2026-09-13 · 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.

81725332019-01: 0 reports for this device; peer average 16.86/device2019-02: 0 reports for this device; peer average 21.63/device2019-03: 0 reports for this device; peer average 14.09/device2019-04: 0 reports for this device; peer average 33.11/device2019-05: 0 reports for this device; peer average 27/device2019-06: 0 reports for this device; peer average 7.91/device2019-07: 0 reports for this device; peer average 17/device2019-08: 0 reports for this device; peer average 11/device2019-09: 0 reports for this device; peer average 13.5/device2019-10: 0 reports for this device; peer average 6.44/device2019-11: 0 reports for this device; peer average 8.57/device2019-12: 0 reports for this device; peer average 9/device2020-01: 0 reports for this device; peer average 6.6/device2020-02: 0 reports for this device; peer average 4.5/device2020-03: 0 reports for this device; peer average 6/device2020-04: 0 reports for this device; peer average 4.29/device2020-05: 0 reports for this device; peer average 4.44/device2020-06: 0 reports for this device; peer average 5.45/device2020-07: 0 reports for this device; peer average 3.09/device2020-08: 0 reports for this device; peer average 2.89/device2020-09: 0 reports for this device; peer average 6.13/device2020-10: 0 reports for this device; peer average 2.4/device2020-11: 0 reports for this device; peer average 2/device2020-12: 0 reports for this device; peer average 4.1/device2021-01: 0 reports for this device; peer average 4.13/device2021-02: 0 reports for this device; peer average 4.43/device2021-03: 0 reports for this device; peer average 6.75/device2021-04: 0 reports for this device; peer average 3.08/device2021-05: 0 reports for this device; peer average 3.71/device2021-06: 0 reports for this device; peer average 3.27/device2021-07: 0 reports for this device; peer average 1.92/device2021-08: 0 reports for this device; peer average 4/device2021-09: 0 reports for this device; peer average 3.56/device2021-10: 0 reports for this device; peer average 2.63/device2021-11: 0 reports for this device; peer average 8/device2021-12: 0 reports for this device; peer average 5.44/device2022-01: 0 reports for this device; peer average 3.22/device2022-02: 0 reports for this device; peer average 1.67/device2022-03: 0 reports for this device; peer average 4.83/device2022-04: 0 reports for this device; peer average 2.67/device2022-05: 0 reports for this device; peer average 2.6/device2022-06: 0 reports for this device; peer average 3.14/device2022-07: 0 reports for this device; peer average 5.4/device2022-08: 0 reports for this device; peer average 3.38/device2022-09: 0 reports for this device; peer average 2.56/device2022-10: 0 reports for this device; peer average 1.78/device2022-11: 0 reports for this device; peer average 1.36/device2022-12: 0 reports for this device; peer average 2/device2023-01: 0 reports for this device; peer average 2.25/device2023-02: 0 reports for this device; peer average 1.71/device2023-03: 0 reports for this device; peer average 2.4/device2023-04: 0 reports for this device; peer average 2.2/device2023-05: 0 reports for this device; peer average 2/device2023-06: 0 reports for this device; peer average 2.14/device2023-07: 0 reports for this device; peer average 1.56/device2023-08: 0 reports for this device; peer average 1.67/device2023-09: 0 reports for this device; peer average 1.8/device2023-10: 0 reports for this device; peer average 2.71/device2023-11: 0 reports for this device; peer average 1.33/device2023-12: 0 reports for this device; peer average 2/device2024-01: 0 reports for this device; peer average 3.17/device2024-02: 0 reports for this device; peer average 2.14/device2024-03: 0 reports for this device; peer average 1.63/device2024-04: 0 reports for this device; peer average 1.4/device2024-05: 0 reports for this device; peer average 1.8/device2024-06: 0 reports for this device; peer average 2/device2024-07: 0 reports for this device; peer average 2.33/device2024-08: 0 reports for this device; peer average 1.2/device2024-09: 0 reports for this device; peer average 1.75/device2024-10: 0 reports for this device; peer average 2.5/device2024-11: 0 reports for this device; peer average 2.67/device2024-12: 0 reports for this device; peer average 2/device2025-01: 0 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 1.5/device2025-04: 0 reports for this device; peer average 1.75/device2025-05: 0 reports for this device; peer average 1.43/device2025-06: 0 reports for this device; peer average 1.67/device2025-07: 0 reports for this device; peer average 2.5/device2025-08: 0 reports for this device; peer average 1.5/device2025-09: 0 reports for this device; peer average 1.33/device2025-10: 0 reports for this device; peer average 1.33/device2025-11: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 2.25/device2026-01: 0 reports for this device; peer average 2/device2026-02: 0 reports for this device; peer average 1.4/device2026-03: 0 reports for this device; peer average 1.67/device2026-04: 0 reports for this device; peer average 2.5/device2026-05: 0 reports for this device; peer average 4/device2026-06: 0 reports for this device; peer average 2/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-01016.86
2019-02021.63
2019-03014.09
2019-04033.11
2019-05027
2019-0607.91
2019-07017
2019-08011
2019-09013.5
2019-1006.44
2019-1108.57
2019-1209
2020-0106.6
2020-0204.5
2020-0306
2020-0404.29
2020-0504.44
2020-0605.45
2020-0703.09
2020-0802.89
2020-0906.13
2020-1002.4
2020-1102
2020-1204.1
2021-0104.13
2021-0204.43
2021-0306.75
2021-0403.08
2021-0503.71
2021-0603.27
2021-0701.92
2021-0804
2021-0903.56
2021-1002.63
2021-1108
2021-1205.44
2022-0103.22
2022-0201.67
2022-0304.83
2022-0402.67
2022-0502.6
2022-0603.14
2022-0705.4
2022-0803.38
2022-0902.56
2022-1001.78
2022-1101.36
2022-1202
2023-0102.25
2023-0201.71
2023-0302.4
2023-0402.2
2023-0502
2023-0602.14
2023-0701.56
2023-0801.67
2023-0901.8
2023-1002.71
2023-1101.33
2023-1202
2024-0103.17
2024-0202.14
2024-0301.63
2024-0401.4
2024-0501.8
2024-0602
2024-0702.33
2024-0801.2
2024-0901.75
2024-1002.5
2024-1102.67
2024-1202
2025-0102
2025-0201
2025-0301.5
2025-0401.75
2025-0501.43
2025-0601.67
2025-0702.5
2025-0801.5
2025-0901.33
2025-1001.33
2025-1101
2025-1202.25
2026-0102
2026-0201.4
2026-0301.67
2026-0402.5
2026-0504
2026-0602
This device (reports/month)Average device in GKZ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Siemens Healthcare Diagnostics Inc.

  • Warning Letter 2012-06-29 Siemens Healthcare Diagnostics, Inc.
  • Warning Letter 2012-06-29 Siemens Healthcare Diagnostics, Inc.
  • Warning Letter 2012-05-29 Siemens Healthcare Diagnostics, Inc.
  • Warning Letter 2012-05-29 Siemens Healthcare Diagnostics, Inc.
  • Warning Letter 2012-05-10 Siemens Healthcare Diagnostics, Inc.
  • Warning Letter 2012-05-10 Siemens Healthcare Diagnostics, Inc.
  • NAI 2026-02-26 Siemens Healthcare Diagnostics Products Ltd. · 0 citations
  • NAI 2024-05-24 Siemens Healthcare Diagnostics, Inc. · 0 citations
  • NAI 2024-05-24 Siemens Healthcare Diagnostics, Inc. · 0 citations
  • NAI 2022-03-30 Siemens Healthcare Diagnostics, Inc. · 0 citations
  • NAI 2022-03-30 Siemens Healthcare Diagnostics, Inc. · 0 citations
  • VAI 2022-03-08 Siemens Healthcare Diagnostics, Inc. · 2 citations
  • VAI 2022-03-08 Siemens Healthcare Diagnostics, Inc. · 2 citations
  • NAI 2021-08-19 Siemens Healthcare Diagnostics Inc · 0 citations
  • NAI 2021-08-19 Siemens Healthcare Diagnostics Inc · 0 citations
  • NAI 2021-03-12 Siemens Healthcare Diagnostics, Inc. · 0 citations
  • NAI 2021-03-12 Siemens Healthcare Diagnostics, Inc. · 0 citations
  • NAI 2019-03-18 Siemens Healthcare Diagnostics Inc. · 0 citations
  • NAI 2018-05-24 Siemens Healthcare Diagnostics Manufacturing Limited · 0 citations
  • VAI 2018-03-02 Siemens Healthcare Diagnostics, Inc. · 4 citations
  • VAI 2018-03-02 Siemens Healthcare Diagnostics, Inc. · 4 citations
  • NAI 2017-11-29 Siemens Healthcare Diagnostics, Inc. · 0 citations
  • NAI 2017-11-29 Siemens Healthcare Diagnostics, Inc. · 0 citations
  • NAI 2017-11-09 Siemens Healthcare Diagnostics Inc · 0 citations
  • NAI 2017-09-26 Siemens Healthcare Diagnostics Inc. · 0 citations
  • NAI 2017-08-25 Siemens Healthcare Diagnostics Inc. · 0 citations