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EliA RF IgM Well

Model DECC056000 · Phadia AB · DI 07333066014814

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
2019-05-10Z-1907-2019Class IITerminatedPotential for reporting low assay resultsk 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

  • K182747 SESE 2018-12-18 (k number procode)
  • K102673 SESE 2011-09-30 (k number procode)

Predicate lineage

K102673 — cites (transitively): K983084 (d1) — cited as predicate by K182747

K182747 — cites (transitively): K091845 (d1), K102673 (d1), K020752 (d2), K020758 (d2), K040449 (d2), K092983 (d2), K983084 (d2) — cited as predicate by K182746

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

Manufacturer compliance record — Phadia AB

  • NAI 2013-11-21 Phadia GmbH · 0 citations
  • NAI 2011-08-18 Phadia Ab · 0 citations
  • NAI 2011-08-18 Phadia Ab · 0 citations