ReQuest Measles IgG Test (Quest) – distribution issue (2025)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Quest International, Inc.
Lot Codes / Batch Numbers
Lot Code: DI# 00850487007357 Lots affected: L07024 and E03025
Products Sold
Lot Code: DI# 00850487007357 Lots affected: L07024 and E03025
Quest International, Inc. is recalling Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/ due to Due to distributing the measles IgG IVD without a premarket approved/cleared.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to distributing the measles IgG IVD without a premarket approved/cleared.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026