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 and LeadCare Plus test Kits. Product Recalled by Magellan Diagnostics, Inc. Due to Underestimates the lead concentration of venous blood samples...
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 and LeadCare Plus test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment Reagent of the Test Kit are specific for lead only. Contents of this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.
Quantity: 6018 kits (total)= 5818 (US)and 200 (OUS)
Why Was This Recalled?
Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems
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