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QUANTA Lite® MPO IgG ELISA

INOVA DIAGNOSTICS, INC. · Model 708700 · UDI-DI 08426950448280

MOB Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

1. 1x MPO IgG ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted MPO IgG ELISA Low Positive 4. 1x 1.2mL prediluted MPO IgG ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

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.