FDA Enforcement
Class II
Ongoing
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
Recall: Z-2552-2025
·
Reported September 17, 2025
Enforcement
- Recall Number
- Z-2552-2025
- Event ID
- 97419
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Quest International, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 17, 2025
- Initiation Date
- July 17, 2025
- Classification Date
- September 11, 2025
- Address
- 8127 Nw 29th St, N/A, Doral, FL, 33122-1051, United States
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
Measles IgM Test Kit lacks premarket approval or clearance.
Code Info
UDI I# 00850487007104 - Lots affected: G00024; K04024; M11024; M12024; D01025; E04025,F04025
Distribution
US Nationwide distribution in the states of Utah, Texas, and Arizona.
Quantity
376 kits