FDA Medical Device Recalls (openFDA)
Quest International, Inc.: 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
- Recall number
- Z-0534-2026
- Recalling firm
- Quest International, Inc.
- 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
- Status
- Open, Classified
- Initiated
- 2025-10-01
- Posted
- 2025-11-17
- Terminated
- not on file
- Reason
- Due to distributing the measles IgG IVD without a premarket approved/cleared.
- Root cause
- No Marketing Application
- Action
- 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.
- Quantity
- not on file
- Distribution
- All products were distributed in the United States. (Utah, Washington).
- Lot, serial or model codes
- Lot Code: DI# 00850487007357 Lots affected: L07024 and E03025
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LJB
- Firm FEI
- 3000206132
- Firm city
- Doral
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06