# FDA recall Z-2552-2025

> **Quest International, Inc.** · Class II · device recall initiated 2025-07-17.

## Product

Brand Name: ReQuest Measles IgM  Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM  Model/Catalog Number: 01-190M  Software Version: N/A  Product Description: Measles IgM tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgM antibodies against measles virus in a patient's serum or plasma  Component: not a component

## Reason for recall

Measles IgM Test Kit lacks  premarket approval or clearance.

## Distribution

US Nationwide distribution in the states of Utah, Texas, and Arizona.

## Key facts

- **Recall number:** Z-2552-2025
- **Recalling firm:** Quest International, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-17
- **Report date:** 2025-09-17

- **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-2552-2025

## Citation

> AI Analytics. FDA recall Z-2552-2025. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-2552-2025. Source: US FDA. Licensed CC0.

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