Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme… — Class II medical device recall Z-0534-2026
Ongoing recall by Quest International, Inc., reported 2025-11-26, distributed in UT, WA. Due to distributing the measles IgG IVD without a premarket approved/cleared.
| Recall number | Z-0534-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Quest International, Inc., Doral, FL, United States |
| Recall initiated | 2025-10-01 |
| Classified | 2025-11-17 |
| Reported by FDA | 2025-11-26 |
| Distributed | UT, WA |
| UPC / GTIN / UDI-DI | 00850487007357 |
| Model numbers | 01-190 |
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 for recall
Due to distributing the measles IgG IVD without a premarket approved/cleared.
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-0534-2026. 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.