FDA recall Z-0534-2026

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.

Distribution

All products were distributed in the United States. (Utah, Washington).

Key facts

Status

Ongoing

Initiation date

2025-10-01

Report date

2025-11-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Doral, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0534-2026