Federal agencies raise safety concerns about Magellan blood-lead analyzers
LeadCare testing devices potentially can return falsely low results
Baltimore, MD (May 18, 2017) – The Department of Health and Mental Hygiene is sharing updated guidance on lead screening for children with Maryland parents and healthcare providers, in light of the health advisory on blood-lead analyzers issued by the federal government yesterday.
On Wednesday, the U.S. Centers for Disease Control and Prevention (CDC) issued a health advisory regarding a safety alert from the U.S. Food and Drug Administration (FDA). The FDA has advised that Magellan Diagnostics’ LeadCare® analyzers (LeadCare, LeadCare II, LeadCare Ultra and LeadCare Plus) should no longer be used for venous blood samples because of the potential for falsely low blood lead test results. At this time, the safety alert does not apply to capillary blood lead test results collected by finger-stick or heel-stick. The CDC has also issued recommendations for health care providers and the public regarding blood lead testing using Magellan Diagnostics’ LeadCare Testing Systems.
Based on recommendations from the FDA and the CDC, Health and Mental Hygiene is making the following recommendations to parents and providers regarding blood lead testing using Magellan Diagnostics’ LeadCare Testing Systems:
1. Health care professionals should re-test patients:
a. Who are younger than 6 years (72 months) of age at the time of this alert (May 17, 2017), and
b. Who had a venous blood lead test result of less than 10 (µg/dL) from a test analyzed using a Magellan Diagnostics LeadCare analyzer.
2. Health care professionals should re-test currently pregnant or lactating women who had a venous blood lead test performed using a Magellan Diagnostics LeadCare Testing System.
3. Parents should discuss re-testing with their health care provider or health department to determine if their child’s blood should be re-tested.
4. Re-testing is not necessary if the healthcare provider is certain that analyzers other than the ones described in the CDC Health Advisory were used to analyze the venous blood samples.
If re-testing indicates blood lead levels exceed the CDC and Maryland reference level of 5 µg, the healthcare provider or public health official should refer to CDC and/or Maryland guidelines for appropriate follow-up action.
Health and Mental Hygiene, along with the Maryland Department of the Environment’s Center for Lead Poisoning Prevention, will continue to monitor developments and will make additional recommendations as necessary. Health and Mental Hygiene also will provide information to clinical laboratories regarding blood lead testing using Magellan’s testing system.
In March 2016, Maryland implemented the Lead-Free Maryland Kids campaign and the updated clinical requirements for blood lead testing of children. The entire state of Maryland is now considered “at risk” for lead exposure, for children born on or after January 1, 2015. As a result, all children born on or after January 1, 2015 must be tested for lead at ages 12 months and 24 months. Children born before January 1, 2015 should continue to be managed according to the 2004 Lead Targeting Plan (which defines specific areas of the state as “at risk”).