Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked… — Class II medical device recall Z-2552-2025
Ongoing recall by Quest International, Inc., reported 2025-09-17, distributed nationwide. Measles IgM Test Kit lacks premarket approval or clearance.
| Recall number | Z-2552-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Quest International, Inc., Doral, FL, United States |
| Recall initiated | 2025-07-17 |
| Classified | 2025-09-11 |
| Reported by FDA | 2025-09-17 |
| Distributed | Nationwide (US) |
| Quantity | 376 kits |
| UPC / GTIN / UDI-DI | 00850487007104 |
| Model numbers | 01-190M |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2552-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.