Up to 7 million tests performed on children since 2014 could have been inaccurate, according to the U.S. Centers for Disease Control and Prevention (CDC). The company that makes the test kits, Massachusetts-based Magellan Diagnostics, says the number is millions lower.
Parents may not realize that lead poisoning screening is a routine part of a check up with a pediatrician. It’s something that can be easily overlooked amid the barrage of questions regarding the child’s development, physical exams, updates on shots and other tests.
Although lead was banned from gasoline, paint and other widely-used consumer products in the late 1970s, poisoning from the chemical is still possible, which is why the CDC recommends that all children be tested.
The U.S. Food and Drug Administration (FDA) recalled the faulty tests in May, and 8 months later we’re still in the dark as to what the problem is.
Medical professionals and families are still dealing with the fallout, which some fear could hurt trust in the screenings and result in fewer parents testing their children.
Amy Winslow, Magellan Diagnostics’ president and CEO, said the company is working with federal regulators and is committed to fixing the problem.
In an October news release, Donald St. Pierre, an FDA director, said millions of families across the U.S. depend on these tests, and that the FDA has “serious concerns” about Magellan Diagnostics’ actions.
“The evidence uncovered during the inspection (of Magellan’s plant) shows that the company put patients at risk after it recognized that its tests could provide inaccurate results and failed to take appropriate steps to report this issue,” Pierre said.
Source: USA Today