May 18, 2017
On May 17, 2017, the Centers for Disease Control and Prevention (CDC) issued a Health Advisory announced that the U.S. Food and Drug Administration (FDA) has issued a safety communication warning about the use of Magellan Diagnostics’ LeadCare® analyzers (LeadCare, LeadCare II, Lead Care Ultra and LeadCare Plus) which may provide inaccurate results for some children and adults in the United States. FDA is now warning that Magellan Diagnostics’ LeadCare® analyzers no longer be used with venous blood samples due to the potential for falsely low test results. The safety alert does not apply to capillary blood lead test results collected by fingerstick or heelstick. The majority of tests performed on LeadCare systems use capillary samples and are performed at the point of care, in provider offices and clinics.
The CDC recommends that healthcare providers re-test patients who are younger than 6 years (72 months) of age at the time of the alert (May 17, 2017) and had a venous blood lead test result of less than 10 micrograms per deciliter analyzed using a Magellan Diagnostics’ LeadCare® analyzer at an onsite (e.g., healthcare facility) or at an offsite laboratory. CDC also recommends that healthcare providers re-test currently pregnant or lactating women who have a venous blood lead test performed using the LeadCare® analyzer. Other adults or parents of children who are concerned about their risk are also encouraged to speak with their healthcare professional about whether they should be retested.
If you or your practice uses the Magellan Diagnostics’ LeadCare® analyzers that are affected by this warning, the CDC recommends that healthcare providers send venous samples to Clinical Laboratory Improvement Amendments (CLIA)-compliant laboratories using inductively coupled plasma mass spectrometry (ICP-MS) or graphite furnace atomic absorption spectrometry (GFAAS) instruments. Capillary samples can also be sent to CLIA-compliant laboratories using any CLIA compliant analyzer including ICP-MS, GFAAS, or LeadCare® analyzers.
Magellan has updated their website to include the following communication. For information on CDC’s Lead Poisoning Prevention program please visit here. The Virginia Department of Health will continue to monitor this situation and provide updates as they are made available.
Marissa J. Levine, MD, MPH, FAAFP
State Health Commissioner