Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010 Recalled by Magellan Diagnostics, Inc. Due to LeadCare Plus and LeadCare Ultra Blood Lead Testing...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Magellan Diagnostics, Inc. directly.
Affected Products
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
Quantity: 1016
Why Was This Recalled?
LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Magellan Diagnostics, Inc.
Magellan Diagnostics, Inc. has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report