Vol. 9, No. 5
May 2017

FDA warns of lead analyzer problems

May 22, 2017 --

The U.S. Food and Drug Administration recently issued a safety warning about the use of Magellan Diagnostics’ LeadCare analyzers with venous blood samples because of the potential of false low test results from the analyzers.

Contents of the Hygienic Lab's blood lead specimen kit.Contents of the Hygienic Lab's blood lead specimen kit.

FDA recommends 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 finger stick or heel stick.

The State Hygienic Lab does not use a Magellan analyzer. SHL performs blood lead testing using the Graphite Furnace Atomic Absorption Spectrometry (GFAAS) method to ensure validity of test results. The Hygienic Lab provides a blood lead specimen collection kit with specimen collection and shipping instructions.