FDA: Lots of pregnant women and kids under 6 tested for lead since 2014 should be retested

A company called Magellan Diagnostics touts itself as "the most trusted name in lead testing." But the Food and Drug Administration disagrees, saying that many of the company's products are inaccurate. The problem may go all the way back to 2014. And the problem appears to be false negatives — some of the company's lead tests show lower-than-actual levels. So, pregnant women who have used the company's products and parents who have had their kids tested with the company's products need to take note. Apparently, many Magellan lead testing products are used in doctors' offices. As the FDA explains:

The U.S. Food and Drug Administration and Centers for Disease Control and Prevention are warning Americans that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in the United States. The CDC recommends that parents of children younger than six years (72 months) of age, and currently pregnant women and nursing mothers who have been tested for lead exposure consult a health care professional about whether they should be retested. * * *

The FDA’s warning is based on currently available data that indicate Magellan lead tests, when performed on blood drawn from a vein, may provide results that are lower than the actual level of lead in the blood. Currently, the FDA believes the issue may date back to 2014. The warning includes all four of Magellan Diagnostics’ lead testing systems: LeadCare; LeadCare II; LeadCare Plus; and LeadCare Ultra. At this time, all LeadCare systems can be used with blood from a finger or heel stick, including the LeadCare II system – a system found in many doctors’ offices and clinics.

The New York Times has coverage here.

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