Pharmaceutical

FDA, CDC warn about faulty lead test

ucm558884 229x210 FDA, CDC warn about faulty lead testCertain tests manufactured by Magellan Diagnostics to check for lead exposure in adults and children may provide inaccurate results, warns the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). As a result, parents of children younger than 6 years of age, currently pregnant women, and nursing mothers who have been tested for lead exposure should consult with a health care professional about whether they should be retested.

“The FDA is deeply concerned by this situation and is warning laboratories and health care professionals that they should not use any Magellan Diagnostics’ lead tests with blood drawn from a vein,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “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.”

The FDA issued the warning based on currently available data that showed 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. At this point, the FDA believes this issue dates back to 2014.

The warning includes all four Magellan Diaagnostics’ lead testing systems – LeadCare, LeadCare II, LeadCare Plus, and LeadCare Ultra. At this point, all LeadCare systems can be used with blood from a finger or heel stick including the LeadCare II system, which is found in many doctors’ offices and clinics.

The CDC is recommending that health care professionals retest children younger than 6 years of age if their test was conducted using blood drawn from a vein using any Magellan Diagnostic’ LeadCare System tests and received a result of less than 10 micrograms per deciliter. The CDC also recommends that women who were tested in this manner while pregnant or nursing, get retested.

Lead exposure can affect nearly every system in the body, produces no obvious symptoms, and is frequently unrecognized, potentially leading to serious health issues. Lead poisoning is particularly dangerous to infants and young children. While recommendation for lead screening differs from state to state, all states require children to be screened for lead exposure.

Source: FDA News Release