Skip Navigation Linksmagellan_info

Childhood Lead Poisoning Prevention branch

Information on Magellan LeadCare®: 2021 Blood Lead Test Kit Recall and 2017 FDA Safety Communications, and Recommendations 

Materials for Medical Providers and Patients

CLPPB Actions

2021 releases related to the LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Test Kit recalls

​On August 31, 2021, Magellan Diagnostics, Inc., began customer notification of an expansion of its May 2021 recall of its LeadCare® Blood Lead Test Kits due to a significant risk of falsely low results, which may lead to health risks especially in special populations such as young children and pregnant and lactating individuals. The recall now includes the majority of all test kits distributed since October 27, 2020. The US Food and Drug Adminstration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these test kits may cause serious injuries. Obtaining falsely low results may lead to patient harm including delayed puberty, reduced postnatal growth, decreased IQ, and attention and behavior problems in children. 

Both the FDA and the US Centers for Disease Control (CDC) have released notifications and recommendations related to this recall.

FDA Alert

CDC Notifications and Recommendations

Testing Kit Shortages

2017 FDA Warning about Magellan LeadCare® Analyzers Producing Falsely Low Results with Venous Blood Samples

  • Some children have not received appropriate retesting related to this 2017 FDA warning.

  • These children should be retested with a capillary or venous sample analyzed using a high complexity device.

FDA Safety Communications


>> For questions, contact Magellan’s LeadCare Product Support Team at 1-800-275-0102 or email: LeadCareSupport@magellandx.com.


​​
Page Last Updated :