Brand Name: ReQuest Measles IgM recallZ-2552-2025 · Quest International, Inc. · initiated Jul 17, 2025

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Quest International, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Measles IgM Test Kit lacks premarket approval or clearance.

FDA root cause category: No Marketing Application

What the company is doing

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.

Recall details

Recall number: Z-2552-2025
Status: Open, Classified
Initiated by the company: Jul 17, 2025
Posted by the FDA: Sep 11, 2025
Recalling firm: Quest International, Inc.
Quantity: 376 kits
Product code: PCL
Distribution: US Nationwide distribution in the states of Utah, Texas, and Arizona.

Product description

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

Code information (models, lots, serial numbers)

UDI I# 00850487007104 - Lots affected: G00024; K04024; M11024; M12024; D01025; E04025,F04025

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

ReQuest MEAS M
Quest International, Inc. · Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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