FDAHealthOctober 1, 2025
Quest International, Inc. — Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Version: N/A Product Description: Me
⚠️ Due to distributing the measles IgG IVD without a premarket approved/cleared.
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- October 1, 2025
All products were distributed in the United States. (Utah, Washington).
What's affected?
- 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
- Lot code
- DI#
Additional details
Lot Code: DI# 00850487007357 Lots affected: L07024 and E03025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated
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