Quest International, Inc. recalls Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-…

Recall date

October 1, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0534-2026

FDA classification

Class II

Brand / firm

Quest International, Inc.

Sold / distributed

All products were distributed in the United States. (Utah, Washington).

Why it was recalled

Due to distributing the measles IgG IVD without a premarket approved/cleared.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Version: N/A Product Description: Measles IgG tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgG antibodies against measles virus in a patient's serum or plasma Component: not a component