🔍 RecallPedia

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 presence of IgM antibodies against measles virus in a patient's serum or plasma Component: not a component

Class I - Dangerous
🏥 Medical Devices Recalled: July 17, 2025 Quest International Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI I# 00850487007104 - Lots affected: G00024; K04024; M11024; M12024; D01025; E04025,F04025
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Quest International, Inc.
Reason for Recall:
Measles IgM Test Kit lacks premarket approval or clearance.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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 presence of IgM antibodies against measles virus in a patient's serum or plasma Component: not a component

Product Codes/Lot Numbers:

UDI I# 00850487007104 - Lots affected: G00024; K04024; M11024; M12024; D01025; E04025,F04025

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2552-2025

Related Recalls

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

Quest International

Class I - Dangerous

Due to distributing the measles IgG IVD without a premarket approved/cleared.

Oct 1, 2025 Diagnostic Equipment View Details →