Device 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
Z-0534-2026
Product summary
- Event
- Event 97763
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-0534-2026
Official wording
Reason: Due to distributing the measles IgG IVD without a premarket approved/cleared.
Code information: Lot Code: DI# 00850487007357 Lots affected: L07024 and E03025
Distribution pattern: All products were distributed in the United States. (Utah, Washington).
Derived failure modes
-
Unknown
Due to distributing the measles IgG IVD without a premarket approved/cleared.