Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-

FDA device recall Z-2552-2025 · posted 2025-09-11 · Open, Classified

Recall details

Recalling firm

Quest International, Inc.

Reason for recall

Measles IgM Test Kit lacks premarket approval or clearance.

Action taken

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.

Root cause

No Marketing Application

Status

Open, Classified

Product code

PCL

Quantity affected

376 kits

Distribution

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

Date initiated

2025-07-17

Date posted

2025-09-11

Location

Doral, FL