Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

ADVIA Centaur® Sample Cups

Model 10309545 · Siemens Healthcare Diagnostics Inc. · DI 00630414221571

FMH — Container, Specimen, Sterile · Class I · 21 CFR 864.3250

UDILibrary device dossier · generated 2026-09-14 · 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 1.5/device2019-02: 0 reports for this device; peer average 2/device2019-03: 0 reports for this device; peer average 3/device2019-04: 0 reports for this device; peer average 2.5/device2019-05: 0 reports for this device; peer average 5/device2019-06: 0 reports for this device; peer average 1.5/device2019-07: 0 reports for this device; peer average 6/device2019-08: 0 reports for this device; peer average 3/device2019-09: 0 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 8/device2019-12: 0 reports for this device; peer average 1.5/device2020-01: 0 reports for this device; peer average 3/device2020-02: 0 reports for this device; peer average 1.5/device2020-03: 0 reports for this device; peer average 1/device2020-04: 0 reports for this device; peer average 1/device2020-05: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 3/device2020-07: 0 reports for this device; peer average 1/device2020-08: 0 reports for this device; peer average 2/device2020-09: 0 reports for this device; peer average 1.5/device2020-10: 0 reports for this device; peer average 1.5/device2020-11: 0 reports for this device; peer average 2/device2020-12: 0 reports for this device; peer average 1.33/device2021-01: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 2/device2021-04: 0 reports for this device; peer average 3/device2021-05: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 1.33/device2021-08: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 1/device2021-10: 0 reports for this device; peer average 4/device2021-11: 0 reports for this device; peer average 1.5/device2021-12: 0 reports for this device; peer average 1/device2022-01: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 2/device2022-03: 0 reports for this device; peer average 1/device2022-04: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 3/device2022-08: 0 reports for this device; peer average 1.33/device2022-09: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 1.5/device2023-03: 0 reports for this device; peer average 1/device2023-04: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 1.33/device2023-06: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 3/device2023-09: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 4/device2023-11: 0 reports for this device; peer average 2.25/device2023-12: 0 reports for this device; peer average 3/device2024-01: 0 reports for this device; peer average 1.5/device2024-02: 0 reports for this device; peer average 2.5/device2024-03: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 2.5/device2024-05: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 1.75/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/device2024-12: 0 reports for this device; peer average 2/device2025-01: 0 reports for this device; peer average 2.6/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 3/device2025-05: 0 reports for this device; peer average 5/device2025-06: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 1.33/device2025-08: 0 reports for this device; peer average 1/device2025-09: 0 reports for this device; peer average 1/device2025-11: 0 reports for this device; peer average 2/device2025-12: 0 reports for this device; peer average 1.33/device2026-01: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 4.25/device2026-04: 0 reports for this device; peer average 2.67/device2026-05: 0 reports for this device; peer average 6.25/device2026-06: 0 reports for this device; peer average 1.25/device0102030405060708091011120102030405060708091011120102030405060809101112010203040608091112010203040506070809101112010203040506070910111201020304050607080911120102040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.5
2019-0202
2019-0303
2019-0402.5
2019-0505
2019-0601.5
2019-0706
2019-0803
2019-0902
2019-1001
2019-1108
2019-1201.5
2020-0103
2020-0201.5
2020-0301
2020-0401
2020-0501
2020-0603
2020-0701
2020-0802
2020-0901.5
2020-1001.5
2020-1102
2020-1201.33
2021-0101
2021-0201
2021-0302
2021-0403
2021-0501
2021-0601.33
2021-0801
2021-0901
2021-1004
2021-1101.5
2021-1201
2022-0101
2022-0202
2022-0301
2022-0401
2022-0603
2022-0801.33
2022-0901
2022-1101
2022-1201
2023-0101
2023-0201.5
2023-0301
2023-0401
2023-0501.33
2023-0601
2023-0702
2023-0803
2023-0901
2023-1004
2023-1102.25
2023-1203
2024-0101.5
2024-0202.5
2024-0302
2024-0402.5
2024-0501
2024-0601
2024-0701.75
2024-0902
2024-1002
2024-1101
2024-1202
2025-0102.6
2025-0201
2025-0301.5
2025-0403
2025-0505
2025-0601
2025-0701.33
2025-0801
2025-0901
2025-1102
2025-1201.33
2026-0101
2026-0204.25
2026-0402.67
2026-0506.25
2026-0601.25
This device (reports/month)Average device in FMH (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