EliA MPOS Well
Model DECC055370 · Phadia AB · DI 07333066014784
MOB — Test System, Antineutrophil Cytoplasmic Antibodies (Anca) · Class II · 21 CFR 866.5660
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)
| Initiated | Recall # | Class | Status | Reason | Link basis |
|---|---|---|---|---|---|
| 2023-05-24 | Z-0783-2024 | Class II | Open, Classified | Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA wells without antigen. | 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.
No dated reports to chart.
Regulatory clearances
- K173792 SESE 2018-03-13 (k number procode)
- K140225 SESE 2014-10-27 (k number procode)
Predicate lineage
K140225 — cites (transitively): K974169 (d1), K981328 (d1), K981330 (d1) — cited as predicate by K173792, K182774
K173792 — cites (transitively): K140225 (d1), K974169 (d2), K981328 (d2), K981330 (d2)
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