FDA and CDC Alerts Regarding Magellan Diagnostics’ LeadCare® Analyzers for Venous Blood Samples

The FDA issued a Safety Communication on May 17th warning against the use of Magellan Diagnostics’ LeadCare® analyzers (LeadCare, LeadCare II, LeadCare Ultra and LeadCare Plus) for venous blood samples because they might result in falsely low test results. According to the FDA, Magellan Diagnostics’ LeadCare® analyzers should no longer be used with venous blood samples. The safety alert does not apply to capillary blood lead test results collected by fingerstick or heelstick. Additional information, including FDA recommendations can be found here.  

CDC has also issued a health alert on this issue, which can be found here. CDC recommendations for retesting are included below and on their website

CDC recommends that healthcare providers re-test patients who:

1) are younger than 6 years (72 months) of age at the time of the alert (May 17, 2017) and
2) had a venous blood lead test result of less than 10 micrograms per deciliter (µg/dL) 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 had a venous blood lead test performed using a Magellan Diagnostics’ LeadCare® analyzer.

CDC recommends parents discuss re-testing with their healthcare provider or health department to determine if their child’s blood should be re-tested.

If re-testing indicates blood lead levels in excess of the CDC reference level (www.cdc.gov/nceh/lead/acclpp/blood_lead_levels.htm), or the state or local action level, the healthcare provider or public health official should refer to CDC and/or local guidelines for appropriate follow-up action (www.cdc.gov/nceh/lead/acclpp/actions_blls.html).

Re-tests are not recommended if the provider is certain that analyzers other than those described by this Health Advisory were used to analyze the venous blood samples.

For future blood lead testing, healthcare providers and public health officials should:

· 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) (also known as electrothermal atomic absorption spectrometry [ETAAS]) instruments.

· Send capillary samples to CLIA-compliant laboratories using any CLIA compliant analyzer including ICP-MS, GFAAS, or LeadCare® analyzers.