Measles IgM test kits recalled for lacking premarket approval or clearance
ReQuest Measles IgM ELISA kits, catalog number 01-190M, are recalled because the test kit lacks premarket approval or clearance. 376 kits are affected.
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: Rubric level 2 covers precautionary recalls; the issue is a regulatory clearance gap rather than any defect described in the product.
Plain-English summary
The ReQuest Measles IgM enzyme linked immunosorbent assay for Rubeola IgM, model and catalog number 01-190M, UDI 00850487007104, is being recalled. Affected lots are G00024, K04024, M11024, M12024, D01025, E04025 and F04025. The recall covers 376 kits distributed in Utah, Texas and Arizona.
The recall was issued because the Measles IgM test kit lacks premarket approval or clearance. The FDA classified the action as Class II. The notice does not describe a defect in the kits.
Laboratories holding affected lots should follow the manufacturer's instructions for return.
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
- regulatory-clearance
- unapproved-device
- class-ii
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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