FDA Warns Against Using Magellan Diagnostics LeadCare Testing Systems

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, LeadCare Ultra and LeadCare Plus) with venous blood samples because they might result in falsely low test results. The FDA is now advising that 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.

CDC recommendations for providers who have used the Magellan Diagnostics LeadCare testing system:

  • – 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)
  • – CDC recommends that healthcare providers re-test patients who 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. 

For future blood lead testing, CDC recommends that 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.
Source : U.S. Food and Drug Administration >
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