Home / Recalls / Quest International, Inc. / Z-0534-2026

Z-0534-2026 Class II Ongoing

Recalled by Quest International, Inc. — Doral, FL

Recall Details

Product Type: Devices
Report Date: November 26, 2025
Initiation Date: October 1, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity

Product Description

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 Pattern

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

Code Information

Lot Code: DI# 00850487007357 Lots affected: L07024 and E03025