The Recall Desk
ModerateFDA (Devices)·Z-1893-2026·Announced 2026-04-29

LeadCare II Blood Lead Test Kit Recall for Inaccurate Results

Magellan Diagnostics is recalling LeadCare II Blood Lead Test Kits because certain third-party micro-collection devices may produce falsely elevated lead results, potentially causing unnecessary testing and delayed results.

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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a test accuracy issue (false positive results) that may cause unnecessary testing and delayed results, which constitutes a moderate risk without documented patient harm.

Plain-English summary

Magellan Diagnostics, Inc. is recalling the LeadCare II Blood Lead Test Kit, LeadCare II 5X Blood Lead Test Kit, and LeadCare II 9X Blood Lead Test Kit (Catalog Numbers 70-6762, 70-6762RUO, 70-8404, and 70-9000) because customers have reported unexpectedly elevated results when certain third-party micro-collection devices are used to collect capillary samples for testing. All lots and sublots are affected.

The issue is that false positive lead results may lead to delayed results and unnecessary additional testing. The affected products have been distributed worldwide, including throughout the United States and to 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, and Vietnam.

Customers and healthcare providers using the LeadCare II test systems with third-party micro-collection devices should contact Magellan Diagnostics for further guidance. More information is available through the FDA's recall database using the agency recall number Z-1893-2026.

The recalled product

Product
(1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits); The LeadCare II kit is p
Manufacturer
Magellan Diagnostics, Inc.
Category
Medical Device — Diagnostic Test Kit
Hazard
  • test-inaccuracy
  • false-positive-results

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 (8)

  • Catalog Number(s): (1) 70-6762
  • (2) 70-6762RUO
  • UDI-DI: 00850355006000
  • ALL lots and ALL sublots
  • Catalog Number(s): (3) 70-8404
  • UDI-DI: 00850355006086
  • Catalog Number(s): (4) 70-9000
  • UDI-DI: 00850355006093

Distribution

Distributed nationwide across the United States.

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