Quest International, Inc. recalls Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay

Measles IgM Test Kit lacks premarket approval or clearance.

On July 17, 2025, Quest International, Inc. issued a "Urgent: Medical Device Recall Notification to affected consignees via E-Mail. Quest International asked consignees to take the following actions: 1. Please examine your inventory and quarantine the affected lot. In addition, if you have distributed the product, you must identify all customers that have received the affected product and immediately notify them. 2. Please ask your customers to discontinue the use of the affected product(s) lot of the Measles IgM Test Kit immediately. 3. We ask that you and your customers discard all affected products in accordance with all local, state, and federal disposal procedures. 4. Please complete and return the enclosed Medical Device Recall Response Form as soon as possible.

• FDA enforcement recordOfficial FDA database entry for Z-2552-2025
• FDA device classification · PCLOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.3520The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Quest International, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.