Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01
Summary
The FDA issued a Class II for Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoa by Quest International, Inc.. Reason: Due to distributing the measles IgG IVD without a premarket approved/cleared..
Details
Source
Device Recall
External ID
Z-0534-2026
Action Date
2025-11-26
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: Lot Code: DI# 00850487007357 Lots affected: L07024 and E03025
Reason for Recall
Due to distributing the measles IgG IVD without a premarket approved/cleared.
Distribution
All products were distributed in the United States. (Utah, Washington).
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-01
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 222 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-0534-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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