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.
CDC recommends that healthcare providers re-test patients who:
1) are younger than 6 years (72 months) of age at the time of the alert (May 17, 2017) and
2) had a venous blood lead test result of less than 10 micrograms per deciliter (μg/dL) analyzed using a Magellan Diagnostics’ LeadCare® analyzer at an onsite (e.g., healthcare facility) or at an offsite laboratory.
CDC also recommends that healthcare providers re-test currently pregnant or lactating women who had a venous blood lead test performed using a Magellan Diagnostics’ LeadCare® analyzer.
CDC recommends parents discuss re-testing with their healthcare provider or health department to determine if their child’s blood should be re-tested.