Recall Z-0534-2026— Quest International, Inc.
Class II · Ongoing
Class II FDA medical device recall by Quest International, Inc., initiated 2025-10-01. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Quest International, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-10-01
- Firm location
- Doral, FL, United States
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
Reason for recall
Due to distributing the measles IgG IVD without a premarket approved/cleared.
Data sourced from openFDA. This site is unofficial and independent of the FDA.