FDA: Inaccurate Lead Tests ID'd, Retests Necessary for Some

The FDA, CDC warning only extends to tests conducted on blood drawn from a vein
The FDA, CDC warning only extends to tests conducted on blood drawn from a vein

Certain lead tests manufactured by Magellan Diagnostics may have provided inaccurate results to patients, according to the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention.

Specifically, the Agency is warning clinicians and patients that Magellan lead tests performed on blood drawn from a vein may provide data that are lower than the actual level of lead present in the blood. The FDA believes this error may date back to 2014. 

The affected tests include all of Magellan Diagnostics' lead testing systems:

  • LeadCare
  • LeadCare II
  • LeadCare Plus
  • LeadCare Ultra

At this time, the warning only extends to tests conducted on blood drawn from a vein; all LeadCare systems can be used with blood drawn from a finger or heel stick. In addition, other types of lead testing methods are not believed to be affected. 

The CDC recommends healthcare professionals retest children currently aged <6 years if their test was done (using blood from a vein) with any Magellan Diagnostics' LeadCare System test and they received a result of <10mcg/dL. In addition, pregnant women and nursing mothers who were tested in this way should also be retested. Other adults who are concerned about their risk or the risk to an older child should consult with a healthcare professional about whether retesting is needed. 

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Lead exposure shows no obvious symptoms and often goes unnoticed, which can lead to serious adverse events. Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, stated, “The agency is aggressively investigating this complicated issue to determine the cause of the inaccurate results and working with the CDC and other public health partners to address the problem as quickly as possible.”

On the heels of the FDA warning, the American Academy of Pediatrics (AAP) released a statement urging parents of children 6 years of age and younger who received a venous blood test for lead to discuss with their child's pediatrician whether a new test is needed. "The AAP will work with our pediatrician members to provide those families impacted by today's warning with the resources and guidance they need to protect their children from lead exposure,” said Fernando Stein, MD, FAAP, president of the AAP.

For more information visit FDA.gov.