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NOVA Lite® ANCA Formalin Kit

INOVA DIAGNOSTICS, INC. · Model 708295 · UDI-DI 08426950554103

MOB Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

1. 10x 6-well ANCA Neutrophil substrate slides (formalin-fixed) 2. 1x 1mL pANCA Positive Control (prediluted) 3. 1x 1mL ANA Positive Control (prediluted) 4. 1x 1mL IFA System Negative Control 5. 1x7mL anti Human IgG AFF Fluorescein with Evans Blue 6. 2x 25mL PBS II Concentrate (40x) 7. 1x 3mL 1% Evans Blue Counterstain 8. 1x 3mL Mounting Medium 9. 1x 10 Coverslips 10. 1x Instruction leaflet

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.