Safety Alert: Class II: Measles IgM Test Kit lacks premarket approval or clearance.
healthClass IIRecalled on Sep 17, 2025
Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay
🔢 376 kits
Sold At: Quest International, Inc.(US Nationwide distribution in the states of Utah, Texas, and Arizona.)
Recall #: FDA-DEVICE-Z-2552-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- UDI I# 00850487007104 - Lots affected: G00024; K04024; M11024; M12024; D01025; E04025,F04025
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Summary
Measles IgM Test Kit lacks premarket approval or clearance.
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact Quest International, Inc. for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.