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FDA & CDC Issue Blood Lead Test Safety Alert for Certain Lead Tests Manufactured Magellan Diagnostics

Friday, May 26, 2017

DISTRICT OF COLUMBIA, May 23, 2017 – The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) recently issued a blood lead test safety alert stating that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in the United States. When performed on blood drawn from a vein, these particular machines may provide results that are lower than the actual level of lead in the blood.

The FDA/CDC safety alert is in effect for the entire U.S. and these machines are in use world-wide. However, this health advisory only applies to children who were under six years of age as of May 17, 2017, as well as individuals who are currently pregnant or nursing.

The District’s Department of Health (DOH) and Department of Energy and Environment (DOEE) recommend the public follow CDC’s guidance. CDC recommends that parents of children younger than six years (72 months) of age at the time of this alert should consult their health care provider about whether they should be retested. The CDC also recommends that individuals who are currently pregnant or nursing and were tested in this manner while pregnant or nursing contact their health care provider about whether they should be retested.

The CDC’s website includes a wealth of information for parents on preventing children’s exposure to lead: https://www.cdc.gov/nceh/lead/parents.htm

Any questions regarding the ongoing investigation related to this alert may be directed to the FDA at 1-(888) INFO-FDA. Questions regarding the retesting recommendations may be directed to CDC at 1 (800) CDC-INFO.