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Home › FDA recalls › Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG E
CLASS II · ModerateFDA

Quest International, Inc. recalls Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant A

📅 Oct 1, 2025 · 📍 UT, WA
Recalling company
Quest International, Inc.
Product
Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Version: N/A Product Description: Measles IgG tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgG antibodies against measles virus in a patient's serum or plasma Component: not a component
Reason
Due to distributing the measles IgG IVD without a premarket approved/cleared.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Oct 1, 2025
Reported
Nov 26, 2025
Distribution
All products were distributed in the United States. (Utah, Washington).
Status
Ongoing
Lot / codes
Lot Code: DI# 00850487007357 Lots affected: L07024 and E03025
Company location
Doral, FL
Recall type
Voluntary: Firm initiated
Recall number
Z-0534-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0534-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.