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QUANTA LITE® Gliadin IgG II ELISA Bulk Pack (Lab Corp)

INOVA DIAGNOSTICS, INC. · Model 704520.10L · UDI-DI 08426950594024

MST Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

1. 10x Gliadin IgG II ELISA Plate 2. 5x 1.2mL Gliadin IgG II ELISA Low Positive 3. 5x 1.2mL Gliadin IgG II ELISA High Positive 4. 10x 10mL HRP IgG Conjugate 5. 10x 10mL TMB Chromogen 6. 10x 10mL HRP Stop Solution 7. 9 x50mL HRP Sample Diluent 8. 10x 25mL HRP Wash Concentrate, 40x concentrate 9. 5x 1.2mL ELISA Negative Control

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.