"Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning", the FDA said in a safety communication. The FDA along with the Centers for Disease Control and Prevention urged the population to retest children, pregnant and breastfeeding women who tested their blood with the faulty test.
Lead exposure can lead to serious health problems, and is particularly unsafe to infants and young children.
During a call with reporters, Jeffrey E. Shuren, MD, director of the Center for Devices and Radiological Health at the FDA, said that at this time the warning only applies to Magellan LeadCare testing from a venous blood draw, and that there is "no evidence" of inaccurate results from capillary blood draws, such as a fingerstick or heel stick.
"We understand that parents of children and others affected by this problem will be concerned about what this means for their health", said Patrick Breysse, Ph.D., director of the CDC's National Center for Environmental Health.
The tests under scrutiny are made by Magellan Diagnostics, which discovered as far back as 2014 that its tests could yield inaccurate results when used on blood drawn from a vein, Food and Drug Administration officials said in a news conference. About 8 million tests were conducted using Magellan devices since 2014. "All of Magellan's LeadCare tests can be used with blood obtained from a finger or heel stick", Kotz said.
He said the company did not alert the FDA to the problem.
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It's safe to use all LeadCare systems that rely on blood from a finger or heel stick, including the LeadCare II system, which is found in many doctors' offices and clinics, the officials said.
The CDC recommended that health care providers retest all children who are now 6 years of age or younger who had testing taken from the vein with a result of 10 micrograms per deciliter that was analyzed using a Magellan diagnostics analyzer, MDHHS's statement says.
Doctors say pregnant and nursing women, as well as kids under the age of 6 should ask their doctors if they should be retested. She said the company's Ultra and Plus systems, launched in 2013 and 2015 respectively, are typically used to analyze venous blood, though they can analyze capillary blood as well.
Lead exposure can affect almost every system in the body, produces no obvious symptoms, and frequently goes unrecognized, potentially leading to serious health issues. On Nov. 24, the company instructed its customers to implement a 24-hour incubation period with the blood sample before running the test. It may have to do with other aspects, including the tubes in which the blood is collected. Magellan also is trying to switch labs now using vein blood to testing from skin sticks.
And the FDA says it's aggressively investigating why these tests can give inaccurate results. Shuren added that while the Magellan LeadCare system is the only FDA-cleared test specifically for lead and the primary source of lead testing for doctor's offices and clinics in the USA, it is "not the only method of testing", he said.