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AQUIOS IMMUNO-TROL Low Cells

Model B25700 · BECKMAN COULTER IRELAND INC. · DI 15099590225865

JPK — Mixture, Hematology Quality Control · Class II · 21 CFR 864.8625

OYE — Flow Cytometric Reagents And Accessories. · Class II · 21 CFR 864.5220

UDILibrary device dossier · generated 2026-09-11 · 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.

23562019-02: 0 reports for this device; peer average 4/device2019-09: 0 reports for this device; peer average 2/device2020-01: 0 reports for this device; peer average 2/device2020-05: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 2.25/device2020-07: 0 reports for this device; peer average 3.33/device2020-08: 0 reports for this device; peer average 1.25/device2020-09: 0 reports for this device; peer average 4/device2020-10: 0 reports for this device; peer average 3.75/device2020-11: 0 reports for this device; peer average 4/device2020-12: 0 reports for this device; peer average 4/device2021-01: 0 reports for this device; peer average 2/device2021-02: 0 reports for this device; peer average 1.8/device2021-03: 0 reports for this device; peer average 2.67/device2021-04: 0 reports for this device; peer average 3.5/device2021-05: 0 reports for this device; peer average 2/device2021-06: 0 reports for this device; peer average 2.2/device2021-07: 0 reports for this device; peer average 2.67/device2021-08: 0 reports for this device; peer average 2.4/device2021-09: 0 reports for this device; peer average 1.33/device2021-10: 0 reports for this device; peer average 2/device2021-11: 0 reports for this device; peer average 2/device2021-12: 0 reports for this device; peer average 2.4/device2022-01: 0 reports for this device; peer average 2/device2022-02: 0 reports for this device; peer average 2/device2022-03: 0 reports for this device; peer average 2.25/device2022-04: 0 reports for this device; peer average 6/device2022-05: 0 reports for this device; peer average 2/device2022-06: 0 reports for this device; peer average 1.33/device2022-07: 0 reports for this device; peer average 3.75/device2022-08: 0 reports for this device; peer average 3/device2022-09: 0 reports for this device; peer average 1.75/device2022-10: 0 reports for this device; peer average 3/device2022-11: 0 reports for this device; peer average 1.8/device2023-01: 0 reports for this device; peer average 4.5/device2023-02: 0 reports for this device; peer average 2.8/device2023-03: 0 reports for this device; peer average 3/device2023-04: 0 reports for this device; peer average 1.67/device2023-05: 0 reports for this device; peer average 1/device2023-06: 0 reports for this device; peer average 1.6/device2023-07: 0 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 1.5/device2023-10: 0 reports for this device; peer average 2.25/device2023-11: 0 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 1.25/device2024-01: 0 reports for this device; peer average 2/device2024-02: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1.67/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 2/device2024-07: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 1/device2024-09: 0 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 1.33/device2025-03: 0 reports for this device; peer average 1/device2025-04: 0 reports for this device; peer average 2/device2025-05: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 1/device2025-09: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 1/device020901050607080910111201020304050607080910111201020304050607080910110102030405060708091011120102030405060708090203040507080910
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0204
2019-0902
2020-0102
2020-0501
2020-0602.25
2020-0703.33
2020-0801.25
2020-0904
2020-1003.75
2020-1104
2020-1204
2021-0102
2021-0201.8
2021-0302.67
2021-0403.5
2021-0502
2021-0602.2
2021-0702.67
2021-0802.4
2021-0901.33
2021-1002
2021-1102
2021-1202.4
2022-0102
2022-0202
2022-0302.25
2022-0406
2022-0502
2022-0601.33
2022-0703.75
2022-0803
2022-0901.75
2022-1003
2022-1101.8
2023-0104.5
2023-0202.8
2023-0303
2023-0401.67
2023-0501
2023-0601.6
2023-0701
2023-0801
2023-0901.5
2023-1002.25
2023-1101
2023-1201.25
2024-0102
2024-0201
2024-0301.67
2024-0402
2024-0501
2024-0602
2024-0701
2024-0801
2024-0902
2025-0201.33
2025-0301
2025-0402
2025-0501
2025-0701
2025-0801
2025-0901
2025-1001
This device (reports/month)Average device in JPK, OYE (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — BECKMAN COULTER IRELAND INC.

  • NAI 2013-05-01 Beckman Coulter Ireland, Inc. · 0 citations
  • VAI 2013-03-28 Beckman Coulter Ireland Inc. · 0 citations
  • VAI 2011-03-10 Beckman Coulter Ireland, Inc. · 2 citations