Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
LeadCare II Blood Lead Test Kit-For in vitro diagnostic use Recalled by Magellan Diagnostics, Inc. Due to During an internal audit a small percentage (<10%)...
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
LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary whole blood.
Quantity: 11,442 LeadCare II kits (549,216 tests)
Why Was This Recalled?
During an internal audit a small percentage (<10%) of plastic caps used to close the treatment reagent tubes were found to not meet the minimum dimensional lip requirement and may have inadequate cap-to-tube seals. Manufacturing with these caps may result in cap-to-tube seals that allow leaking of HCl or may result in cap-to-tube seals that allow evaporation of treatment reagent. The consequence of this would be a change in the volume of treatment reagent and a change in the ratios of either added patient sample or control material to treatment reagent. The result of this might be a falsely elevated result (e.g., a patient false positive [PATFP] result or a Controls Out of Range-High [COOR-Hi] result).
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