FDA warns some lead tests might be inaccurate

(The information in this post is duplicated from an original AMCHP Legislative Alert received via email on 5/17/17.)

The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) warned that certain lead tests manufactured by Magellan Diagnostics may provide inaccurately low results for some children, pregnant women and nursing mothers. The CDC recommends that parents of children younger than six years (72 months) old, as well as pregnant women and nursing mothers who have been tested for lead exposure, consult a health care professional about whether they should be retested.

The CDC recommends that health care providers retest children younger than age six as of today if:

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

AMCHP participated in a conference call with the CDC and the FDA, where officials explained the following:

  • The low blood lead level readings are specific to venous blood.
  • The  extent of lead underestimation is unclear because of small samples.
  • There are no indications yet of such underestimation involving capillary blood from a finger or heel stick.

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