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News FDA & CDC Issue “Blood Lead Test Safety Alert”

FDA warns Americans about risk of inaccurate results from certain lead tests.
5/17/2017
  • Childhood Lead Poisoning Prevention Program
  • Bureau of Environmental Health
  • Department of Public Health

May 17, 2017: FDA warns against using Magellan Diagnostics LeadCare Testing Systems with blood obtained from a vein.

For parents of young children

This alert is important if you have a child age younger than 6 yrs who was tested for blood lead using a LeadCare instrument.  Parents and guardians should contact their child’s health care provider to find out if this alert applies to their child.

For health care providers and laboratories

Mass CLPPP is urging health care providers and laboratories to notify parents and guardians of children to whom this alert applies and arrange for a retest.

CDC recommends that any child under age 6 as of May 17, 2017 who was tested for lead using venous blood analyzed on any type of lead care instrument (LeadCare, LeadCare 2, LeadCare Plus or LeadCare Ultra) and whose test result was under 10 mcg/dL be retested. Please see the CDC Health Alert Network notice for more information and re-testing details (CDC Advisory).

CDC also recommends that women who are currently pregnant or breast feeding and were tested on a LeadCare instrument be retested.

Note: Medicaid will cover the cost of retesting for children enrolled in Medicaid. Families with private health insurance should contact their insurance company about coverage.

Additional resources

Childhood Lead Poisoning Prevention Program 

We help prevent, screen, diagnose, and treat lead poisoning. We work to eliminate sources of poisoning through research and educational, epidemiological, and clinical activities.

Bureau of Environmental Health 

BEH protects the public health from a variety of environmental exposures. We respond to environmental health concerns and provide communities with epidemiologic and toxicological health assessments. Our regulatory programs enforce statutes and regulations related to food protection, radiation protection, childhood lead exposure, and minimum standards for housing, recreational camps, swimming pools, etc.

Department of Public Health 

DPH promotes the health and well-being of all residents by ensuring access to high-quality public health and healthcare services, and by focusing on prevention, wellness and health equity in all people.

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