FDAHealthJuly 17, 2025
Quest International, Inc. — 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 Test Kit lacks premarket approval or clearance.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 17, 2025
US Nationwide distribution in the states of Utah, Texas, and Arizona.
What's affected?
- Product
- 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
- Lot code
- affected:
Additional details
UDI I# 00850487007104 - Lots affected: G00024; K04024; M11024; M12024; D01025; E04025,F04025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 376 kits.
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