FDA warns Americans about risk of inaccurate results from certain lead tests.

May 17, 2017: FDA warns against using Magellan Diagnostics LeadCare Testing Systems with blood obtained from a vein. Please click on the following links for more information:

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:

Massachusetts Childhood Lead Poisoning Prevention Program
1-800-532-9571
www.mass.gov/dph/clppp

Massachusetts State Lead Lab
617-983-6665
http://www.mass.gov/dph/bls

CDC Lead Program
https://www.cdc.gov/nceh/lead/


This information is provided by the Childhood Lead Poisoning Prevention Program within the Department of Public Health.