Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test Recalled by Magellan Diagnostics, Inc. Due to Defect with the calibration button for lot 1808M....
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 LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II 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 the LeadCare II Blood Lead Test Kit must only be used with a LeadCare II Analyzer.
Quantity: 1,465 kits
Why Was This Recalled?
Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values will generate results of HIGH (>65 ¿g/dL). Results for patient testing with this lot will be displayed as HIGH.
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