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NOVA Lite® DAPI ANCA (Formalin) Kit

INOVA DIAGNOSTICS, INC. · Model 704337 · UDI-DI 08426950767046

MOB Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

1. 1 x 7mL Mounting Medium 2. 1 x 15mL FITC IgG Conjugate with DAPI 3. 1 x Coverslips (20 ea) 4. 1 x 0.5mL IFA System Negative Control 5. 1 x 0.5mL cANCA Positive 6. 1 x 0.5mL pANCA Positive 7. 20 x ANCA (Formalin Fixed Human Neutrophil) Slide (12 well) 8. 2 x 25mL PBS II Concentrate (40x)

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.