Brand Name: ReQuest Measles IgG recallZ-0534-2026 · Quest International, Inc. · initiated Oct 1, 2025

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Quest International, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Due to distributing the measles IgG IVD without a premarket approved/cleared.

FDA root cause category: No Marketing Application

What the company is doing

On 10/01/2025, the firm email an "URGENT: Medical Device Recall Measles IgG IFU" letter to customers informing them that the Measles IgG Medical Device is subject to the limitations of exemption from premarket notification (510(k)) under 21 CFR866.9(c)(7) and is subject to the 510(k) premarket requirements prior to being marketed and distributed in the U.S. Customers are instructed to examine their inventory, discontinue use and quarantine the affected lot and review the updated Instruction for Use (IFU) and ensure all relevant personnel are informed of the changes. The previous version of the IFU should be replace with the updated version, Revision 9. The updated IFU (Revision 9) can also be requested by contacting Customer Support team at [email protected]. Awareness Technology, Inc. will be revising the intended use of the product to be only for qualitative detection of human IgG antibodies to measles virus in human serum by enzyme immunoassay. The company will also be removing language in the Instructions for Use (IFU) that could be interpreted as determining immune status, statements regarding paired sera for demonstrating seroconversion or significant rise in antibody levels, and any reference to semi-quantitative procedures. The updated IFU (Revision 9) will be included in all product shipments starting 10/01/2025. For questions or assistance, contact Customer Service at [email protected].

Recall details

Recall number: Z-0534-2026
Status: Open, Classified
Initiated by the company: Oct 1, 2025
Posted by the FDA: Nov 17, 2025
Recalling firm: Quest International, Inc.
Product code: LJB
Distribution: All products were distributed in the United States. (Utah, Washington).

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

Code information (models, lots, serial numbers)

Lot Code: DI# 00850487007357 Lots affected: L07024 and E03025

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

SeraQuest MEAS G
Quest International, Inc. · Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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