Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM ...
FDA Recall #Z-2552-2025 — Class II — July 17, 2025
Product Description
Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-190M Software Version: N/A Product Description: Measles IgM tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgM antibodies against measles virus in a patient's serum or plasma Component: not a component
Reason for Recall
Measles IgM Test Kit lacks premarket approval or clearance.
Recalling Firm
Quest International, Inc. — Doral, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
376 kits
Distribution
US Nationwide distribution in the states of Utah, Texas, and Arizona.
Code Information
UDI I# 00850487007104 - Lots affected: G00024; K04024; M11024; M12024; D01025; E04025,F04025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated