ReQuest Measles IgM Test (Quest) – FDA Approval Missing (2025)
Test kit lacks FDA premarket approval, potentially posing diagnostic risks.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Quest International, Inc.
Lot Codes / Batch Numbers
UDI I# 00850487007104 - Lots affected: G00024, K04024, M11024, M12024, D01025, E04025, F04025
Products Sold
UDI I# 00850487007104 - Lots affected: G00024; K04024; M11024; M12024; D01025; E04025,F04025
Quest International, Inc. is recalling Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model due to Measles IgM Test Kit lacks premarket approval or clearance.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Measles IgM Test Kit lacks premarket approval or clearance.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026