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FDA: Maker of blood lead test used flawed procedures :

July 13, 2017

Federal officials investigating the manufacturer of a blood lead test that provided inaccurate results have found nine flaws in the company’s practices.

The new Food and Drug Administration (FDA) report follows its announcement in May that Magellan Diagnostic Inc.’s LeadCare systems used for venous tests were found to underestimate blood lead levels, providing some patients with a false negative.

“We are carefully reviewing the evidence collected during the inspection to determine if there have been violations of federal law and whether further action is warranted,” Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a statement.

FDA inspectors found the tests’ validation studies didn’t account for immediate blood analysis. They also found problems with the company’s risk analysis, complaint procedures, reports to the FDA and procedures for design change, according to the report.

Doctors should continue to follow advice from the FDA and Centers for Disease Control and Prevention issued May 17 recommending children be retested using another method if they meet all the following criteria:

  • under 6 years old as of May 17,
  • had a venous test evaluated on the Magellan LeadCare Testing Systems, and
  • had a blood lead level less than 10 µg/dL.

Pregnant or lactating women who had one of these tests also should be retested. Families with concerns should speak with their doctor to determine if retesting is necessary.

Lead exposure has been associated with health, learning and behavior problems, and no amount is considered safe.

Pediatricians should ask families regularly about risk factors like low socioeconomic status, recent immigration and living in older buildings, and follow up with appropriate testing and resources. They also can educate parents regarding sources of lead like lead-based paints, toys, cosmetics, ethnic spices, certain occupations and hobbies, and water from corroding plumbing.

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