Magellan Diagnostics recalled its LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests due to a significant risk of falsely low blood lead level results. The FDA expressed concerns that the falsely low results may contribute to health risks in special populations such as young children and pregnant individuals. A pregnant or lactating individual’s exposure to lead may cause health problems for the parent and the developing baby. Obtaining falsely low blood lead level results can also lead to inappropriate follow-up assessments, which may result in patient harm, including delayed puberty, reduced postnatal growth, decreased IQ, and inattention and behavior problems in children.

The FDA notified the Centers for Disease Control on June 24, 2021 that some Magellan Diagnostics blood lead test kits were undergoing a voluntary recall by the manufacturer. The FDA now recommends that Magellan Diagnostics customers discontinue the use of all affected test kit lots identified as part of the recall and quarantine remaining inventory.

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