Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-1

FDA device recall Z-0534-2026 · posted 2025-11-17 · Open, Classified

Recall details

Recalling firm

Quest International, Inc.

Reason for recall

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

Action taken

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 jopain@awartech.com. 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 jcopain@awaretech.com.

Root cause

No Marketing Application

Status

Open, Classified

Product code

LJB

Distribution

All products were distributed in the United States. (Utah, Washington).

Date initiated

2025-10-01

Date posted

2025-11-17

Location

Doral, FL