Home / Recalls / Quest International, Inc. / Z-2552-2025

Z-2552-2025 Class II Ongoing

Recalled by Quest International, Inc. — Doral, FL

Recall Details

Product Type: Devices
Report Date: September 17, 2025
Initiation Date: July 17, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 376 kits

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.

Distribution Pattern

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