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

Amos Gonzales
May 18, 2017

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.

The tests, manufactured by Magellan Diagnostics, are commonly used in doctors' offices and clinics, and on its website the company calls itself "the most trusted name in lead testing".

Federal agencies are warning the public that certain lead tests may provide inaccurate results, but the state Department of Public Health said it's been warning people about these tests for more than a year.

According to the MDHHS, 1.7 percent of blood tests done in MI on children under 6 years old since 2014 were done using Magellan equipment from a venous draw.

Studies have shown many US public water supplies are contaminated by lead.

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.

The CDC on Wednesday recommended retesting children younger than six years if their test was conducted using blood drawn from a vein using any Magellan tests and received a result of less than 10 micrograms per deciliter (µg/dL).

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"These recommendations are being made to ensure that children who continue to have exposures in environments that contain lead are assessed and receive the resources needed to stop the exposure", said Jennifer A. Lowry, M.D., FAAP, chair of the AAP Council on Environmental Health Executive Committee. The institutions noted that the problem could go as far back as 2014. The CDC also recommends that women, who are now pregnant or nursing and were tested in this manner while pregnant or nursing, get 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.

The reasons why the tests are inaccurate is still unknown, but Shuren says the FDA is "aggressively" investigating the issue along with the CDC and other public health partners "to address the problem as quickly as possible", according to the statement.

Any adult or child who had blood drawn for a lead test since 2014 may have to be re-tested, the FDA said.

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. If the results show elevated lead levels, they need to be confirmed through a venous test in which blood is drawn from the arm. "We believe most people will not be affected by this issue".

Despite decades of US progress in curbing lead poisoning, millions of children remain at risk.

Adults with high lead levels are at risk of developing problems with memory and concentration, while pregnant women will high lead levels are more at risk of miscarriage, stillbirth or premature birth.

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