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
Reported: September 17, 2025 Initiated: July 17, 2025 #Z-2552-2025
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
Reason for Recall
Measles IgM Test Kit lacks premarket approval or clearance.
Details
- Recalling Firm
- Quest International, Inc.
- Units Affected
- 376 kits
- Distribution
- US Nationwide distribution in the states of Utah, Texas, and Arizona.
- Location
- Doral, FL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Quest International, Inc.. Units affected: 376 kits.
Why was this product recalled? ▼
Measles IgM Test Kit lacks premarket approval or clearance.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 17, 2025. Severity: Moderate. Recall number: Z-2552-2025.
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