FDAFDA · Food and drugs·Recall number Z-2552-2025
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
Published September 17, 2025 · Recall initiated: July 17, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Measles IgM Test Kit lacks premarket approval or clearance.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Quest International, Inc.
- Distributor
- US Nationwide distribution in the states of Utah, Texas, and Arizona.
- Lot
- UDI I# 00850487007104 - Lots affected: G00024; K04024; M11024; M12024; D01025; E04025,F04025
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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