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Model OSR61105 · Beckman Coulter, Inc. · DI 15099590010966

DHR — System, Test, Rheumatoid Factor · Class II · 21 CFR 866.5775

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.

11222024-02: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 1/device2024-11: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 2/device2026-06: 0 reports for this device; peer average 2/device0210110806
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2024-0201
2024-1001
2024-1101
2025-0802
2026-0602
This device (reports/month)Average device in DHR (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K060201 — cited as predicate by K191562

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

Manufacturer compliance record — Beckman Coulter, Inc.

  • Warning Letter 2024-03-15 Beckman Coulter, Inc.
  • Warning Letter 2024-03-15 Beckman Coulter, Inc.
  • Warning Letter 2011-11-01 Beckman Coulter, Inc.
  • Warning Letter 2011-11-01 Beckman Coulter, Inc.
  • Warning Letter 2011-08-01 Beckman Coulter Inc.
  • Warning Letter 2011-08-01 Beckman Coulter Inc.
  • Warning Letter 2010-06-21 Beckman Coulter Inc.
  • Warning Letter 2010-06-21 Beckman Coulter Inc.
  • NAI 2025-01-17 Beckman Coulter, Inc. · 0 citations
  • NAI 2025-01-17 Beckman Coulter, Inc. · 0 citations
  • OAI 2023-12-11 Beckman Coulter, Inc. · 0 citations
  • OAI 2023-12-11 Beckman Coulter, Inc. · 0 citations
  • VAI 2021-10-28 Beckman Coulter, Inc. · 2 citations
  • VAI 2021-10-28 Beckman Coulter, Inc. · 2 citations
  • NAI 2021-08-05 Beckman Coulter Inc. · 0 citations
  • NAI 2021-08-05 Beckman Coulter Inc. · 0 citations
  • NAI 2019-10-30 Beckman Coulter Inc. · 0 citations
  • NAI 2019-10-30 Beckman Coulter Inc. · 0 citations
  • VAI 2017-10-16 Beckman Coulter, Inc. · 4 citations
  • VAI 2017-10-16 Beckman Coulter, Inc. · 4 citations
  • VAI 2017-02-02 Beckman Coulter GmbH · 2 citations
  • NAI 2016-05-20 Beckman Coulter Inc · 0 citations
  • VAI 2016-01-27 Beckman Coulter, Inc. · 2 citations
  • VAI 2016-01-27 Beckman Coulter, Inc. · 2 citations
  • VAI 2015-03-11 Beckman Coulter, Inc. · 1 citations
  • VAI 2015-03-11 Beckman Coulter, Inc. · 1 citations
  • NAI 2015-02-05 Beckman Coulter Inc · 0 citations
  • NAI 2015-02-05 Beckman Coulter Inc · 0 citations