Quest International, Inc.: Device Recall
Recall #Z-2552-2025 · 07/17/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2552-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Quest International, Inc.
- Status
- Ongoing
- Date Initiated
- 07/17/2025
- Location
- Doral, FL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 376 kits
Reason for Recall
Measles IgM Test Kit lacks premarket approval or clearance.
Product Description
Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-190M Software Version: N/A Product Description: Measles IgM tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgM antibodies against measles virus in a patient's serum or plasma Component: not a component
Distribution Pattern
US Nationwide distribution in the states of Utah, Texas, and Arizona.
Other Recalls by Quest International, Inc.
- Class II: Risk 10/01/2025
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.