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Open, Classified

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

FDA Recall Z-2552-2025 · Posted 2025-09-11

Recalling FirmQuest International, Inc.
Recall StatusOpen, Classified
Product CodePCL
Date Initiated2025-07-17
Product Quantity376 kits

Reason for Recall

Measles IgM Test Kit lacks premarket approval or clearance.

Firm Action

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

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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