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.
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.
Both the FDA and the US Centers for Disease Control (CDC) have released notifications and recommendations related to this recall.
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.
Safety Issue on Magellan Diagnostics LeadCare Testing Systems (last updated 09/27/2021)
>> For questions, contact Magellan’s LeadCare Product Support Team at 1-800-275-0102 or email: LeadCareSupport@magellandx.com.