Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay M...
FDA Recall #Z-0534-2026 — Class II — October 1, 2025
Product Description
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
Reason for Recall
Due to distributing the measles IgG IVD without a premarket approved/cleared.
Recalling Firm
Quest International, Inc. — Doral, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Distribution
All products were distributed in the United States. (Utah, Washington).
Code Information
Lot Code: DI# 00850487007357 Lots affected: L07024 and E03025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated