F.D.A. Warns of Faulty Lead Testing in Children as well as Mothers


Christina Murphy watched as her 3-year-old daughter, Lilly, reached for a bottle of water to use during bath time at their home in Flint, Mich., where the family avoided using tap water because of concerns about lead.

Brittany Greeson for The brand new York Times

Some blood tests used to check for lead poisoning in children as well as women since 2014 may have wrongly indicated in which children were safe by lead exposure, federal health officials warned Wednesday. Children under 6 as well as pregnant as well as nursing women may need to be retested.

The concern can be in which the original tests may have underestimated blood lead levels, providing false reassurance to parents. Infants as well as young children are especially vulnerable to the effects of lead poisoning, which can cause cognitive deficits as well as affect almost every system inside the body.

The tests under scrutiny are made by Magellan Diagnostics, which discovered as far back as 2014 in which its tests could yield inaccurate results when used on blood drawn by a vein, Food as well as Drug Administration officials said in a news conference.

For young children, many doctors use less invasive finger sticks or heel sticks to draw samples of capillary blood for testing, as well as F.D.A. officials said there can be no evidence at This kind of point in which the finger- as well as heel-pricking methods have provided inaccurate results.

They emphasized in which they have just started out their investigation.

“The F.D.A. can be deeply concerned by This kind of situation as well as can be warning laboratories as well as health care professionals in which they should not use any Magellan Diagnostics lead tests with blood drawn by a vein,” said Dr. Jeffrey Shuren, director of the F.D.A.’s Center for Devices as well as Radiological Health. “The agency can be aggressively investigating This kind of complicated issue to determine the cause of the inaccurate results.”

Magellan, which calls itself “the most trusted name in lead testing,” did not return calls for comment.

F.D.A. officials did not provide estimates of how many people may have been at risk for a faulty test. Although Magellan can be the only test approved for immediate lead testing in a doctor’s office or clinic, This kind of’s not clear how many tests were given by drawing blood by a vein or by a pin prick.

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F.D.A. Warns of Faulty Lead Testing in Children as well as Mothers

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