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U.S. Department of Health and Human Services

Class 2 Device Recall ReQuest Measles IgM

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 Class 2 Device Recall ReQuest Measles IgMsee related information
Date Initiated by FirmJuly 17, 2025
Date PostedSeptember 11, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2552-2025
Recall Event ID 97419
Product Classification Enzyme linked immunoabsorbent assay, rubeola IgM - Product Code PCL
ProductBrand 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 UDI I# 00850487007104 - Lots affected: G00024; K04024; M11024; M12024; D01025; E04025,F04025
FEI Number 3000206132
Recalling Firm/
Manufacturer		 Quest International, Inc.
8127 Nw 29th St
Doral FL 33122-1051
For Additional Information ContactSteve Andrus
+1-772-2836540
Manufacturer Reason
for Recall		Measles IgM Test Kit lacks premarket approval or clearance.
FDA Determined
Cause 2		No Marketing Application
ActionOn 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.
Quantity in Commerce376 kits
DistributionUS Nationwide distribution in the states of Utah, Texas, and Arizona.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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