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NOVA Lite® ANCA Kit

INOVA DIAGNOSTICS, INC. · Model 708299 · UDI-DI 08426950594055

MOB Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

1. 10x 6-well ANCA ethanol-fixed human neutrophil substrate slides 2. 1x 4mL FITC Anti Human IgG Conjugate 3. 1x 0.5 mL cANCA Positive 4. 1x 0.5 mL pANCA Positive 5. 1x 0.5mL IFA System Negative Control 6. 1x 25mL PBS II Concentrate (40x) 7. 1x 7mL Mounting Medium 8. 1x 10 Coverslips

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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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.