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

Materials for Medical Providers and Patients

• Fact sheet for medical providers (PDF)
• Retest fact sheet for patients affected by recall (English and Spanish, PDF)
• Additional recall information for affected patients (English and Spanish, PDF)

CLPPB Actions

• CLPPB Fact Sheet - response to recall / warnings (PDF)

2022 updates and 2021 releases related to the LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Test Kit recalls

2022 Updates

FDA March 30, 2022: Magellan Diagnostics has resumed distribution of the LeadCare II product, which was previously unavailable. LeadCare Plus and LeadCare Ultra products are currently unavailable.

2021 Releases

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. View affected lot numbers. 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.

FDA Alert

• September 28, 2021 - FDA, Magellan Diagnostics Recalls LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests Due to Risk of Falsely Low Results
  

CDC Notifications and Recommendations

• November 5, 2021 - CDC Health Alert Network (HAN) - Update: Expansion of Recall of LeadCare® Blood Lead Tests Due to Risk of Falsely Low Results
  
• October 2021 - CDC LeadCare® Expanded Recall FAQ (PDF)
  

Testing Kit Shortages

• CDC Recommendations - Potential Shortage of Test Kits Following Recall 
  

Update from Magellan

• February 16, 2022 - Magellan Diagnostics announced it had resumed manufacturing and distribution of LeadCare® II test kits
  

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

• CDC, Health Alert Network (HAN) notification, Potential for Falsely Low Blood Lead Test Results from LeadCare® Analyzers (archived document - last reviewed 05/17/2017)
  

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