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 Recalled by Magellan Diagnostics, Inc. Due to LeadCare II Test Kits controls out of range
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, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls (two levels), heparinized capillary tubes and plungers, transfer droppers and a calibration button. The LeadCare II Lead Controls packaged in the kit lots listed in #2 below are the subject of this recall (Field Correction) action.
Quantity: 12,931 kits
Why Was This Recalled?
LeadCare II Test Kits controls out of range
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