The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are urging providers to stop using Magellan Diagnostics’ LeadCare Analyzers with venous blood samples, as the tests could produce falsely low blood lead test results.

Affected analyzers include the company’s LeadCare, LeadCare II, LeadCare Ultra, and LeadCare Plus products. Capillary blood lead tests, which use a fingerstick or heelstick, are not included in this safety alert.

CDC has reached out to public health departments to locate the affected analyzers and recommends providers retest blood lead levels in:

  • patients younger than 6 years old as of May 17;
  • patients whose blood lead test results using a LeadCare analyzer, in both onsite and offsite laboratories, were less than 10 micrograms per deciliter; and
  • pregnant or lactating women who had a blood lead test with a LeadCare analyzer.

Providers should refer to CDC guidelines for follow-up action if retests show blood lead levels exceeding the CDC reference level or local action level.

Contact Director of Policy Erin O’Malley at eomalley@essentialhospitals.org or 202.585.0127 with questions.