# FDA recall Z-0534-2026

> **Quest International, Inc.** · Class II · device recall initiated 2025-10-01.

## 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

- **Recall number:** Z-0534-2026
- **Recalling firm:** Quest International, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-01
- **Report date:** 2025-11-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Doral, FL, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0534-2026. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0534-2026. Source: US FDA. Licensed CC0.

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