Has your child had a lead test in the past three years?
Then he might need to be tested again.
The FDA, CDC, and AAP are warning about a possible problem with lead tests that have been done on children since 2014.
FDA Blood Lead Test Safety Alert
Specifically, the FDA is warning about all four of Magellan Diagnostics’ lead testing systems, including their LeadCare, Lead Care II, LeadCare Plus, and LeadCare Ultra test, as they might “provide results that are lower than the actual level of lead in the blood.”
Your child is not affected if they:
- are over 6 years old (as of May 17, 2017)
- had a lead test done from a finger or heel stick (the warning is about tests done on blood drawn from a vein, like in their arm)
- had a lead test done using a different, non-Magellan Diagnostics testing method
- had a lead test that was higher than 10 micrograms per deciliter (as they would hopefully have undergone retesting and a look for possible sources of lead exposure in and around their home if it was over 10)
Where are these Magellan Diagnostics’ lead testing systems used? They are used in some doctors’ offices and clinics and in some laboratories that do lead testing.
“While most children likely received an accurate test result, it is important to identify those whose exposure was missed, or underestimated, so that they can receive proper care. For this reason, because every child’s health is important, the CDC recommends that those at greatest risk be retested.”
Dr. Patrick Breysse, PhD, CIH, director of CDC’s National Center for Environmental Health
The American Academy of Pediatrics is also “urging parents of children ages 6 and younger who received a venous blood test for lead (in which blood is drawn from the arm), to discuss with their child’s pediatrician whether a new test is needed.”
Risks for Lead Poisoning
Do we still need to worry about high lead levels and lead poisoning so long after lead was removed from paint and gasoline?
It is estimated that children in at least 3 to 4 million households in the United States are still exposed to high lead levels.
Children are especially at higher risk if they:
- live in a home built before 1978, with the risk increasing with the age of the home, especially if it was built before 1960
- have family members, friends, or neighbors with lead poisoning
- live in a community with high levels of lead poisoning in children or a possible source of lead contamination, like a lead smelter or battery recycling plant
- have pica (eat non-food substances)
- are exposed to alternative medicine that might be contaminated with lead
- live with a family member that works has a hobby in the lead-industry
And the latest recommendations are that all children have a risk assessment for high lead levels when they are 6-12 months old and again at 18-24 months. Those at high risk, on Medicaid, or in high prevalence areas should be formally tested at those ages.
What to Know About the FDA Blood Lead Test Safety Alert
If your child is under age six years and “had a venous blood lead test result of less than 10 (µg/dL) from a test analyzed using a Magellan Diagnostics’ LeadCare analyzer,” then he or she needs to have a repeat lead test.
More About the FDA Blood Lead Test Safety Alert
- CDC – Blood Lead Test Safety Alert
- FDA – FDA Warns Against Using Magellan Diagnostics LeadCare Testing Systems with Blood Obtained from a Vein: FDA Safety Communication
- AAP – American Academy of Pediatrics Urges Parents to Confirm Lead Tests Following FDA Warning
- AAP – Lead Exposure: Steps to Protect Your Family
- AAP – Where We Stand: Lead Screening
- AAP – Blood Lead Levels in Children: What Parents Need to Know
- CDC – Advisory Committee On Childhood Lead Poisoning Prevention (ACCLPP)
Last Updated on May 17, 2017 by Vincent Iannelli, MD
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