Health Alert Network (HAN) No. 403 - Potential for Falsely Low Blood Lead Test Results from LeadCare® Analyzers

The U.S. Food and Drug Administration (FDA) has issued a safety communication warning about the use of Magellan Diagnostics’ LeadCare® analyzers (LeadCare, LeadCare II, LeadCare Ultra and LeadCare Plus) with venous blood samples because they might result in falsely low test results. FDA is now advising that Magellan Diagnostics’ LeadCare® analyzers should no longer be used with venous blood samples. The safety alert does not apply to capillary blood lead test results collected by fingerstick or heelstick. The purpose of this Health Advisory is to notify state and local health departments, healthcare providers, and laboratories about CDC’s re-testing guidance in light of the safety alert.

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