FDA & CDC Warning: Faulty Lead Tests from Magellan Diagnostics

May 19, 2017 | Anastasia Sonneman

Earlier this week the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) issued a warning stating that certain lead tests manufactured by Magellan Diagnostics may yield inaccurately low readings of lead levels in children, pregnant women, and nursing mothers. Based on this warning, the CDC recommends that all children under the age of six years as well as women who are pregnant or nursing, who were previously tested for lead exposure, immediately consult a health care professional to determine if there is a need for subsequent testing. Health care providers are urged to retest children under the age of six based on the following criteria:

  • the child’s first test was conducted using blood drawn from a vein using any Magellan Diagnostics’ LeadCare System tests; and
  • the child received a result of less than 10 micrograms per deciliter (µg/dL).

Local health departments should inform their community members and local health care providers about this warning and related recommendations as soon as possible. Click here to access the full FDA press release. Local health officials are encouraged to visit the following webpages for additional resources and information related to preventing risks associated with lead exposure:


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