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IMMCO DIAGNOSTICS

IMMCO DIAGNOSTICS, INC. · Model 1140-250 · UDI-DI 00845714000577

MOB Prescription
10
510(k) clearances
3
Adverse events (1 deaths)
1
Recalls
25
Facilities

Description

Anti-neutrophil Cytoplasmic Antibody (ANCA) IFA Kit

Recalls

DateFirmReason
2023-05-24Phadia AbComplaints 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 w

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.