FDA Medical devices recall ·
ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay… recall
- Recall number
- Z-2552-2025
- Date
- (initiated July 17, 2025)
- Company / brand
- Quest International, Inc.
8127 Nw 29th St, Doral, FL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 376 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Measles IgM Test Kit lacks premarket approval or clearance.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI I# 00850487007104 - Lots affected: G00024; K04024; M11024; M12024; D01025; E04025,F04025
Distribution
US Nationwide distribution in the states of Utah, Texas, and Arizona.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2552-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.