FDA recall Z-2552-2025

Quest International, Inc. · Class II · 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

Reason for recall

Measles IgM Test Kit lacks premarket approval or clearance.

Distribution

US Nationwide distribution in the states of Utah, Texas, and Arizona.

Key facts

Status
Ongoing
Initiation date
2025-07-17
Report date
2025-09-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Doral, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2552-2025