Quick Facts at a Glance
- Recall Date
- July 17, 2025
- Hazard Level
- HIGH
- Brand
- Quest International
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, INFANTS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Quest International
- Product type
- Measles IgM Test Kit (ELISA)
- Model numbers
- 01-190M, UDI I# 00850487007104, G00024, K04024, M11024, M12024, D01025, E04025 +1 more
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 17, 2025
Reported by FDA DEVICE
September 17, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Measles IgM Test Kit lacks premarket approval or clearance.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Quest International, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
Measles IgM ELISA kits are used in clinical labs to detect recent measles infection by identifying IgM antibodies in patient serum or plasma.
Why This Is Dangerous
The regulatory gap means the kit has not undergone FDA premarket review, potentially compromising test validity and patient safety.
Industry Context
This recall is not part of a broader industry pattern for misclassified devices.
Real-World Impact
High risk to clinical accuracy and patient management; clinics may need to halt testing and switch to FDA-cleared alternatives.
Practical Guidance
How to identify if yours is affected
- Locate model 01-190M on the kit label.
- Check UDI printed as 00850487007104.
- Look for lot number G00024.
Where to find product info
Kits display model, lot, and UDI on the exterior label and packaging.
What timeline to expect
Refund or replacement timelines vary by manufacturer; expect weeks for processing after return.
If the manufacturer is unresponsive
- File a complaint with the FDA if the company is unresponsive.
- Consult your healthcare provider for alternatives.
How to prevent similar issues
- Verify FDA premarket clearance before purchasing diagnostic tests.
- Prefer kits with explicit clearance documentation.
- Maintain inventory records and serial numbers for recalls.
Documentation advice
Keep all recall notices, purchase receipts, lot numbers, and correspondence with the manufacturer.
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Product Details
Brand: Quest International. Product: Measles IgM Enzyme Linked Immunoassay Kit. Model/Catalog: 01-190M. Other models/UDI: UDI I# 00850487007104, lots affected G00024. Quantity: 376 kits. Distribution: US nationwide in Utah, Texas, Arizona.
Reported Incidents
No incidents or injuries are reported in the provided data. Hazard classification remains high due to regulatory status.
Key Facts
- 376 kits recalled nationwide
- Model 01-190M and related UDI: 00850487007104
- Lots affected: G00024
- Distribution: Utah, Texas, Arizona
- Hazard: lacks premarket approval/clearance
- Action: stop use immediately
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Safety Guide
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