"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.
Healthcare professionals and public health laboratories should discontinue using Magellan's LeadCare System Testing System with venous blood samples, due to concerns about inaccurately low results, said the FDA in a safety communication. This problem may even go back to as far as 2014, the agencies said.
The FDA indicated that all four of Magellan Diagnostic's lead testing systems - LeadCare II, LeadCare, LeadCare Ultra, and LeadCare Plus - may have provided faulty results by performing tests on vein-drawn blood. The lead poisoning tests are made by Magellan Diagnostics.
However, lead testing using blood taken from a vein is not widespread.
Lead exposure can lead to serious health problems, and is particularly risky to infants and young children. In addition, pregnant women and nursing mothers who were tested in this way should also be retested. At the time, the company looked into the issue and determined the risk for inaccurate results could be mitigated by delaying processing of the test for 24 hours.
It is unclear why Magellan lead tests perform differently with venous blood than with capillary blood from a finger or heel stick, FDA said.
Federal officials are warning that some blood tests may have "significantly" underestimated lead levels, and they are urging the retesting of some children, as well as pregnant and breast-feeding women. The recommendations do not apply to tests taken from a finger or heel stick.
Though Magellan had identified another inaccuracy issue with an additional product in 2015, that information was not conveyed to the FDA during the 510 (k) process despite repeated interactions, Dr. Shuren said, because the company saw it as a low-risk issue it considered resolved.
Patrick Breysse, director of the CDC's National Center for Environmental Health, said, "We understand that parents of children and others affected by this problem will be concerned about what this means for their health".
The CDC's threshold for elevated lead is 5 micrograms per deciliter of blood.
Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said that the FDA investigation is now in its early phases, so most people are not likely to be affected. The FDA noted that it hadn't found any evidence of problems with the capillary blood samples. Higher lead levels can cause damage to the kidneys and nervous system, while very high levels can be fatal, the Mayo Clinic states.
The tests are created to detect lead poisoning that can stunt children's growth and reduce their IQs, according to the Centers for Disease Control and Prevention. "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.