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FDA, CDC Warn Certain Lead Tests May Produce Too-Low Results
March 23 2018, 10:45 | Rex Rios
The FDA officials believe that roughly 8 million blood tests may have been conducted using a Magellan-developed testing system since 2014.
Certain lead tests manufactured by Magellan Diagnostics may have provided inaccurate results to patients, according to the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention. "There is little evidence that Magellan tests using blood from a finger or heel stick are affected", Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said during a morning media briefing. The problem applies only to tests where blood was drawn from a vein, not the more common lead tests that involve pricking a finger or heel to get a blood sample.
Magellan is working closely with the FDA to address the situation, and is offering finger-stick testing instead of venous tests.
The lead poisoning tests are made by Magellan Diagnostics. CDC recommends that health care professionals retest children younger than aged 6 years at the time of this alert if their test was performed with blood drawn from a vein using any Magellan Diagnostics' LeadCare System tests and received a result of less than 10 mcg/dL. 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 US, it is "not the only method of testing", he said. Lead exposure produces no apparent symptoms and often goes unrecognized and can lead to serious health issues. Although Magellan is the only test approved for immediate lead testing in a doctor's office or clinic, it's not clear how many tests were given by drawing blood from a vein or by a pin prick.
A representative from the Centers for Medicare and Medicaid Services said that the Medicaid program "should pay for the cost of re-testing" kids on Medicaid, and that those with private insurance should consult their healthcare plan.
However, on April 28, Magellan notified customers they should no longer use the blood collection tubes, and that they should also discontinue the 24-hour incubation method. In addition, pregnant women and nursing mothers who were tested in this way should also be retested. Those kinds of blood draws are usually done in labs. 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.
The FDA learned about the problem earlier this year when it began to review an application for a new test. But if those levels are elevated, a follow up test is done with blood drawn from the arm. Infants and young children are especially vulnerable to the effects of lead poisoning, which can cause cognitive deficits and affect nearly every system in the body. Lead poisoning is particularly unsafe to infants and young children.