MDHHS shares FDA announcement about risk of inaccurate results from certain lead tests

Contact: Jennifer Eisner 517-241-2112

FOR IMMEDIATE RELEASE May 17, 2017

LANSING, Mich. – In an effort to reach all Michigan health care providers and the public, the Michigan Department of Health and Human Services (MDHHS) is sharing the recent U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) warning about falsely low blood lead test results from Magellan Diagnostics LeadCare® Analyzers.

The FDA believes the issue may date back to 2014, however the CDC recommends that healthcare providers retest all children who are currently six years of age or younger who had testing taken from the vein with a result of 10 micrograms per deciliter or less analyzed using a Magellan diagnostics analyzer. At this time, the recommendations do not apply to tests taken from a finger or heel stick (capillary draw).

“While less than two percent of the lead tests performed statewide since 2014 were done using this Magellan equipment from a venous draw, we take this issue very seriously and will be working closely with our local health departments and health care providers to ensure they are aware of the recommendations and offering retesting as appropriate,” said Dr. Eden Wells, chief medical executive of MDHHS.  “It’s important to remember that lead does not stay in the blood for very long, so a low test result today may not tell you if there was past exposure. Talk to your physician to determine if retesting is needed for your child.”

The CDC recommends that parents of children currently younger than six years of age, as well as pregnant women and nursing mothers, who had a venous blood lead test result 10 micrograms per deciliter or less analyzed using a Magellan Diagnostics’ LeadCare® analyzer consult with their health care provider about whether they should be retested.

According to most recent data, statewide there were 9,363 test results from 2014 to the present for children under age 6 that had a venous blood lead test done on LeadCare® equipment. This is 1.7 percent of all blood lead tests done during this period. In Flint, where blood lead testing has increased in recent years due to the water crisis, the number of potentially impacted results is 128. To determine if your child’s test may have been impacted, contact their physician.

MDHHS has issued a Health Alert Network (HAN) notification to ensure that local health departments, providers, and other partners in the health care community have received this information from the FDA and CDC. The department will also issue a letter to all health care providers statewide who participate in the Medicaid program to inform them of the situation and to encourage providers to review patient case information to determine if additional testing is warranted.

For more information or to view the FDA announcement, visit the FDA website. The CDC’s recommendations are available on the CDC website. To learn about how to keep your home lead safe, visit michigan.gov/leadsafe.

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