FDA issues warning on accuracy of Magellan Diagnostics’ lead tests

18 May 2017 (Last Updated May 18th, 2017 18:30)

The US Food and Drug Administration (FDA) has issued a warning regarding the use of select Magellan Diagnostics’ lead tests.

FDA issues warning on accuracy of Magellan Diagnostics’ lead tests

The US Food and Drug Administration (FDA) has issued a warning regarding the use of select Magellan Diagnostics’ lead tests.

The FDA and Centers for Disease Control and Prevention (CDC) said that the results from LeadCare, LeadCare II, LeadCare Plus and LeadCare Ultra tests may be inaccurate in some American children and adults.

CDC recommended that children aged less than six years, pregnant women and nursing mothers should seek a health professional for a retest on lead exposure.

FDA Center for Devices and Radiological Health director Jeffrey Shuren said: “The FDA is deeply concerned by this situation and is warning laboratories and healthcare professionals that they should not use any Magellan Diagnostics’ lead tests with blood drawn from a vein.

“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 available data indicated that the lead tests may present results lower than the original level of lead present.

"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."

According to FDA, the problem with the results may date back to 2014. Currently, the tests are being used on blood from a finger or heel stick.

CDC National Center for Environmental Health director Patrick Breysse said: “While most children likely received an accurate test result, it is important to identify those whose exposure was missed or underestimated so that they can receive proper care.

“For this reason, because every child’s health is important, the CDC recommends that those at greatest risk be retested.”

The retests are recommended only if the test has been performed with blood from a vein using any Magellan Diagnostics’ LeadCare Systems and obtained a result less than 10µg/dL.


Image: FDA warns about the risk of inaccurate blood test results by using certain lead tests. Photo: courtesy of meepoohyaphoto via FreeDigitalPhotos.net.