Quick Facts at a Glance
- Recall Date
- March 13, 2026
- Hazard Level
- HIGH
- Brand
- Magellan Diagnostics
- Geographic Scope
- 1 states
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
- Magellan Diagnostics
- Model numbers
- Catalog Number: 70-8098, UDI-DI: 00850355006024, ALL lots and ALL sublots
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 13, 2026
Reported by FDA DEVICE
April 29, 2026
RecallRadar source check
May 6, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Magellan Diagnostics, Inc. or your healthcare provider for instructions. Notification method: Letter
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Full Description
LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Treatment Reagent Tubes (8 containers of 24 each; 192 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL). Reason: Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.. Classification: Class II. Quantity: 284. Distribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Bhutan, Bolivia, Canada, Chile, Diego Garcia, Ecuador, Eritrea, Georgia, Ghana, Guam, Guatemala, Haiti, Hong Kong, India, Indonesia, Israel, Italy, Ivory Coast, Japan, Kyrgyzstan, Mexico, Nepal, Peru, Philippines, South Africa, South Korea, Spain, UAE, Uruguay, Vietnam.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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