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Healthcare professionals and public health laboratories should discontinue using Magellan’s LeadCare Testing System with venous blood samples, due to concerns about inaccurately low results, said the FDA in a safety communication.  Children age 6 and under whose blood was tested for lead using the Magellan System may not have received an accurate result.  The test may underestimate the amount of lead in blood and give normal results when lead levels are actually elevated.

Because of these inaccuracies, the CDC recommended that healthcare professionals re-test children under 6 years of age as of May 17, 2017 who had venous blood test results showing 10 micrograms per deciliter or lower. They added that currently pregnant women and nursing mothers who had a venous blood draw with this system should also be re-tested.

Lead is a heavy metal found naturally in the environment, and it’s common in many consumer products.  It can be dangerous to the developing brains of babies and children, even at low levels, leading to learning disabilities, behavioral problems such as hyperactivity and attention problems, and low birth weight.  At higher levels, lead poisoning can cause seizures, coma and death.

During a call with reporters, Jeffrey E. Shuren, 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.

Shuren said that the FDA first became aware of the issue during a review of a 510(k) premarket submission for a new LeadCare product received from Magellan in March 2017.  The agency discovered that the company “significantly underestimated” the amount of risk to the public, and lacked “adequate data and supporting documentation regarding the cause of the problem and effectiveness of mitigation.”

The agency found out that Magellan received complaints about inaccuracies of the system as far back as 2014, but concluded the risk was “negligible” and resolved if laboratories delayed processing blood samples for 24 hours.

Shuren said that while the FDA and CDC are in the “early stages” of their investigation, they did not want to delay issuing this warning to the public.

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