Quest International, Inc.: Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Versi
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- 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 / hazard
- Due to distributing the measles IgG IVD without a premarket approved/cleared.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- All products were distributed in the United States. (Utah, Washington).
- Recall initiated
- 2025-10-01
- Code info
- Lot Code: DI# 00850487007357 Lots affected: L07024 and E03025
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Doral
- State
- FL
- Country
- United States
- Event id
- 97763
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