Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 0
Summary
The FDA issued a Class II for Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Ass by Quest International, Inc.. Reason: Measles IgM Test Kit lacks premarket approval or clearance..
Details
Source
Device Recall
External ID
Z-2552-2025
Action Date
2025-09-17
Status
Ongoing
Category
device
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
Lot/Code Info: UDI I# 00850487007104 - Lots affected: G00024; K04024; M11024; M12024; D01025; E04025,F04025
Quantity Affected: 376 kits
Reason for Recall
Measles IgM Test Kit lacks premarket approval or clearance.
Distribution
US Nationwide distribution in the states of Utah, Texas, and Arizona.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-17
Company
Doral, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 168 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Quest International, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Quest International, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Quest International, Inc. have FDA actions?
Quest International, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2552-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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