Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0534-2026 — 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

U.S. FDA — Device Enforcement · United States · 2025-10-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0534-2026
Date of alert
2025-10-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Quest International, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00850487007357
Reported risk: Due to distributing the measles IgG IVD without a premarket approved/cleared.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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