Magellan Diagnostics is recalling approximately 198,313 LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Test Kits because they may provide falsely high lead level results. The issue occurs when using certain third-party collection tubes to collect blood from a fingerstick or heelstick. While no injuries have been reported, these false positives can lead to unnecessary clinical testing and delayed care. These kits were distributed worldwide to medical facilities and laboratories between March 2026 and April 2026.
The test kits can produce unexpectedly elevated lead results when blood is collected using specific third-party micro-collection devices. This can result in a false diagnosis of lead poisoning, leading to emotional distress for families and unnecessary follow-up medical procedures for the patient.
The LeadCare II kit includes sensors, treatment reagent tubes, heparinized capillary tubes, plungers, and transfer droppers.
The LeadCare Plus kit includes sensors, treatment reagent tubes, calibration button, and lead controls.
The LeadCare Ultra kit includes sensors, treatment reagent tubes, calibration button, and lead controls.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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