FDAJuly 17, 2025device

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 antibodie...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Measles IgM Test Kit lacks premarket approval or clearance.

What to do

FDA enforcement status: Ongoing

Brands named

quest

UPCs

00850487007104

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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