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Alinity

Model 04R9921 · Abbott GmbH · DI 00380740151058

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

UDILibrary device dossier · generated 2026-09-16 · 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.

Manufacturer compliance record — Abbott GmbH

  • VAI 2024-06-28 Abbott · 3 citations
  • NAI 2020-01-10 Abbott · 0 citations
  • NAI 2018-06-22 Abbott · 0 citations
  • NAI 2018-02-01 Abbott · 0 citations
  • NAI 2016-09-16 Abbott · 0 citations
  • NAI 2013-06-13 Abbott GmbH · 0 citations
  • NAI 2013-06-11 Abbott · 0 citations
  • VAI 2013-03-08 Abbott · 0 citations
  • NAI 2012-02-09 Abbott GmbH · 0 citations
  • NAI 2011-10-05 Abbott · 0 citations
  • VAI 2010-09-23 Abbott GmbH · 0 citations