Measles IgM Test Kit Recalled for Lack of FDA Premarket Clearance
ReQuest Measles IgM test kits manufactured by Quest International lack FDA premarket approval or clearance. Approximately 376 kits distributed nationwide in Utah, Texas, and Arizona are subject to recall.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for an in vitro diagnostic device lacking premarket approval or clearance. No illnesses, injuries, or adverse events have been reported. The hazard is regulatory non-compliance rather than a direct product defect or safety failure.
Plain-English summary
Quest International, Inc. is recalling ReQuest Measles IgM (Enzyme Linked Immunosorbent Assay) test kits, Model 01-190M. Approximately 376 kits are affected. These test kits are designed to detect IgM antibodies against measles virus in patient serum or plasma using an ELISA method.
The kits lack premarket FDA approval or clearance as required for in vitro diagnostic devices. Without such clearance, the safety, effectiveness, and performance of the test kits have not been reviewed and verified by the FDA.
The affected kits were distributed nationwide in Utah, Texas, and Arizona. Affected lot numbers include: G00024, K04024, M11024, M12024, D01025, E04025, and F04025.
Healthcare providers and laboratories using these test kits should immediately discontinue use and contact Quest International for return or replacement instructions. No adverse events or illnesses have been reported associated with use of these test kits.
The recalled product
- Product
- Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-190M Software Version: N/A Product Description: Measles IgM tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the pres
- Manufacturer
- Quest International, Inc.
- Hazard
- lack-of-premarket-clearance
- unvalidated-test-performance
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- UDI I# 00850487007104 - Lots affected: G00024
- K04024
- M11024
- M12024
- D01025
- E04025
- F04025
Distribution
Distributed nationwide across the United States.
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