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ADVIA® Chemistry RF Rheumatoid Factor Reagents

Model 10311894 · Siemens Healthcare Diagnostics Inc. · DI 00630414482385

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

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 (1)

InitiatedRecall #ClassStatusReasonLink basis
2019-08-09Z-0282-2020Class IITerminatedThe assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to re-align to the reference material.k number procode

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

K972220 — cited as predicate by K162263

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

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