Medical device recalls Moderate risk

Quest International, Inc. recalls Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01…

Recall date
July 17, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2552-2025
FDA classification
Class II
Brand / firm
Quest International, Inc.
Sold / distributed
US Nationwide distribution in the states of Utah, Texas, and Arizona.

Why it was recalled

Measles IgM Test Kit lacks premarket approval or clearance.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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