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AccuDiag ™
Diagnostic Automation, Inc. · Model DACD-1681-2 · UDI-DI 00894175000404
10
510(k) clearances
3
Adverse events (1 deaths)
1
Recalls
25
Facilities
Description
AccuDiag ™ ANCA Screen IgG ELISA Kit A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antibodies associated with vasculitis in a clinical specimen, using an enzyme immunoassay (EIA) method. The assayed antibodies may include autoimmune antibodies directed at the glomerular basement membrane (GBM), anti-neutrophil cytoplasmic antibodies to myeloperoxidase (ANCA MPO) and/or anti-neutrophil cytoplasmic antibodies to proteinase-3 (PR3).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-24 | Phadia Ab | 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 w |
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Get your free API keyRead the docsData 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.