FDA: Blood lead tests may have been inaccurate

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Breaking News · May 17, 2017

FDA: Blood lead tests may have been inaccurate by Melissa Jenco · News Content Editor

Some children need to have their blood lead levels rechecked due to inaccurate test results, federal health officials said Wednesday. Magellan LeadCare Testing Systems used for venous tests have been found to underestimate blood lead levels, providing some patients with a false negative, according to the Food and Drug Administration (FDA). "Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning," the FDA said in a safety communication. Lead exposure has been associated with health, learning and behavior problems, and no amount is considered safe. Children in at least 4 million households are exposed to high lead levels, according to the Centers for Disease Control and Prevention (CDC).

The CDC is recommending children be retested using another method if they meet all of the following criteria:

currently under 6 years old,
had a venous test evaluated on the Magellan LeadCare Testing Systems, and
had a blood lead level less than 10 µg/dL.

Pregnant or lactating women who had one of these tests also should be retested. Families with concerns should speak with their doctor to determine if retesting is necessary.