FDA, CDC warn some lead poisoning tests may not be accurate

Certain tests to detect lead poisoning could produce faulty results, regulators warn

Magellan Diagnostics products are used in labs and doctors' offices throughout the United States. Magellan blood tests from finger or heel pricks - the method usually used for children - are considered accurate.

"The FDA is deeply concerned by this situation", Dr. Jeffrey Shuren, head of the FDA's medical device division, said in a statement. Shuren added the FDA is concerned about the wrong results and that a "root cause" has not been identified yet.

MDHHS issued a Health Alert Network notification to ensure that local health departments, providers, and others in the health care community have received information from the FDA and CDC.

The FDA officials believe that roughly 8 million blood tests may have been conducted using a Magellan-developed testing system since 2014.

Lead poisoning is especially unsafe to babies and young children.

The CDC recommended that health care professionals retest children younger than six years of age who were tested using any Magellan Diagnostics' LeadCare System tests and received a result of less than 10 micrograms per deciliter.

The FDA is now warning certain lead tests may be faulty, and young children and pregnant women may need to be re-tested.

In a letter to customers, Magellan Diagnostics advised that facilities discontinue using venous blood samples with their testing systems.

"At this time we believe most people will not be affected by this issue", Shuren said on a conference call with reporters. But if those levels are elevated, a follow up test is done with blood drawn from the arm. Shuren said that such devices are handled under a process that is less hard than the one used for drug approvals, and that it requires companies to demonstrate that the devices are safe and efficient.

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"There may be differences in how the blood is collected, the tubes that may be used for it, or some of the other processing, and that may account for why there are differences", he said.

They emphasized that they have just started their investigation.

Studies have shown many US public water supplies are contaminated by lead. "For those who are covered privately, we would encourage folks to consult with their health plan".

Lead testing in children is typically done by a finger or heel stick known as capillary test.

Data indicate that when all four of Magellan's lead testing systems - LeadCare; LeadCare II; LeadCare Plus; and LeadCare Ultra - are performed on blood drawn from a vein, they may give results that are lower than the actual level of lead in the blood. The FDA noted that it hadn't found any evidence of problems with the capillary blood samples.

If you think you or your child needs another lead test, talk with your doctor.

"Today at least 4 million households have children living in them that are being exposed to high levels of lead".

Lead exposure shows no obvious symptoms and often goes unnoticed, which can lead to serious adverse events.

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