FDA Warns of Inaccurate Lead Test Results, CDC Recommends Re-Test for Certain Pregnant or Lactating Women

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. As a result, the Centers for Disease Control and Prevention (CDC) is now recommending that health care providers re-test currently pregnant or lactating women who had a venous blood lead test performed using a Magellan Diagnostics’ LeadCare® analyzer.

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.

For more information about the warning, additional recommendations, and future blood lead testing see FDA’s safety communication warning. See also the American College of Obstetricians and Gynecologists’ (ACOG’s) Committee Opinion on Lead Screening During Pregnancy and Lactation, ACOG’s Committee Opinion on Exposure to Toxic Environmental Agents, CDC’s lead website, and Project TENDR’s Targeting Environmental Neuro-Developmental Risks (including recommendations on lead) for more information.

Advertisement

American Congress of Obstetricians and Gynecologists
409 12th Street SW, Washington, DC  20024-2188 | Mailing Address: PO Box 70620, Washington, DC 20024-9998