Device 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
Z-2552-2025
Product summary
- Event
- Event 97419
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 376 kits
- Official record key
device-enforcement:Z-2552-2025
Official wording
Reason: Measles IgM Test Kit lacks premarket approval or clearance.
Code information: UDI I# 00850487007104 - Lots affected: G00024; K04024; M11024; M12024; D01025; E04025,F04025
Distribution pattern: US Nationwide distribution in the states of Utah, Texas, and Arizona.
Derived failure modes
-
Unknown
Measles IgM Test Kit lacks premarket approval or clearance.