Z-0534-2026Class II

Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog...

Name: Z-0534-2026 Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog...
Creator: Quest International, Inc.
Published: 2025-10-01
License: https://open.fda.gov/license/

Quest International, Inc. / initiated 2025-10-01 / Open, Classified

FDA source

Quest International, Inc. began a recall of Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Version: N/A Product... on 2025-10-01. FDA classified it as Class II and gives the reason as "Due to distributing the measles IgG IVD without a premarket approved/cleared". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0534-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-01
Posted: 2025-11-17
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
Product code: LJB Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
Reason for recall: Due to distributing the measles IgG IVD without a premarket approved/cleared.
FDA 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 [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].
Distribution: All products were distributed in the United States. (Utah, Washington).
Product codes and lots: Lot Code: DI# 00850487007357 Lots affected: L07024 and E03025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0534-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0534-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-26	2025-11-17

Product code LJB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)