Quest International, Inc.: Device Recall
Recall #Z-0534-2026 · 10/01/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0534-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Quest International, Inc.
- Status
- Ongoing
- Date Initiated
- 10/01/2025
- Location
- Doral, FL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
Reason for Recall
Due to distributing the measles IgG IVD without a premarket approved/cleared.
Product Description
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
Distribution Pattern
All products were distributed in the United States. (Utah, Washington).
Other Recalls by Quest International, Inc.
- Class II: Risk 07/17/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.