FDA Medical devices recall ·
ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked… recall
- Recall number
- Z-0534-2026
- Date
- (initiated October 1, 2025)
- Company / brand
- Quest International, Inc.
8127 Nw 29th St, Doral, FL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Version: N/A Product Description: Measles IgG tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgG antibodies against measles virus in a patient's serum or plasma Component: not a component
Why was it recalled?
Due to distributing the measles IgG IVD without a premarket approved/cleared.
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
Lot Code: DI# 00850487007357 Lots affected: L07024 and E03025
Distribution
All products were distributed in the United States. (Utah, Washington).
States: Utah Washington
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-0534-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.