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QUANTA Lite® Gliadin IgA ELISA

INOVA DIAGNOSTICS, INC. · Model 708655 · UDI-DI 08426950485995

MST Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

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

Recalls

Date	Firm	Reason
2023-05-01	Phadia US Inc	Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument
2023-05-01	Phadia US Inc	Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument
2008-03-21	Diamedix Corporation	Standards and controls in the Is-anti-Gliadin IgG Test Kits are exhibiting low activity. A drop in the O.D.s the Positive Control could potentially recover low out of range (which

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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.