PROVIDENCE, R.I. (WPRI) – Approximately 1,500 Rhode Islanders who’ve been tested for lead exposure should be retested because their results may be inaccurate, according to the Rhode Island Department of Health.
The Centers for Disease Control and the U.S. Food and Drug Administration issued a warning about certain lead tests manufactured by Magellan Diagnostics. According to the FDA, results from the venous lead tests may be lower than the actual level of lead in the blood.
The issue may date back to 2014, and includes four Magellan Diagnostics lead testing systems, according to the FDA.
- LeadCare II
- LeadCare Plus
- LeadCare Ultra
“The FDA is deeply concerned by this situation,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “The agency is aggressively investigating this complicated issue to determine the cause of the inaccurate results and working with the CDC and other public health partners to address the problem as quickly as possible.”
Because of the recent warning, the Rhode Island Department of Health has been in touch with physicians who have patients whose blood was tested by a laboratory that used one of these analyzers. The agency is also sending letters directly to pediatric patients’ parents.
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The CDC is recommending new lead tests for children younger than six if their original lead test results showed less than 10 micrograms per deciliter. The CDC also recommends retesting for women who are pregnant or nursing who had a venous blood lead test performed using a Magellan Diagnostics’ LeadCare analyzer.
Lead exposure can cause serious health issues, including damage to the brain and nervous systems, slowed growth and development, learning and behavior problems, and hearing and speech problems, according to the CDC.