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QUANTA LITE® Gliadin IgA II ELISA Bulk Pack Lab Corp

INOVA DIAGNOSTICS, INC. · Model 704525.10L · UDI-DI 08426950593973

MST Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

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

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.