Magellan Diagnostics, Inc. and the U.S. Food and Drug Administration (FDA) have issued notifications about the expansion of Magellan Diagnostics’ recall of LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests, which were distributed from October 27, 2020, to August 19, 2021. Additional LeadCare II product lots, including lots previously reported to be unaffected, were recalled due to a significant risk of falsely low results. The use of these devices may cause serious injuries because they might underestimate blood lead levels. FDA has identified this as a Class I recall, the most serious type of recall.
The Centers for Disease Control and Prevention (CDC) is issuing this Health Alert Network (HAN) Health Update to notify healthcare providers and state and local health departments about the expansion of the recall notice and to recommend appropriate follow-up actions in the shortage of LeadCare Lead Tests. This HAN Health Update is an update to HAN Health Advisory 445: Recall of LeadCare Blood Lead Tests Due to Risk of Falsely Low Results that CDC issued on July 6, 2021.
Magellan Diagnostics, Inc. is recalling LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Test kits due to a significant risk of falsely low blood lead level results. FDA has 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 is concerning because it may cause health problems for the parent and the developing baby. Obtaining falsely low blood lead level results may lead to patients not receiving appropriate follow-up assessments, which may result in patient harm, including delayed puberty, reduced postnatal growth, decreased IQ, and attention and behavior problems in children.
FDA initially notified CDC on June 24, 2021, that some Magellan Diagnostics blood lead test kits were undergoing a voluntary recall by the manufacturer. FDA recommended that Magellan Diagnostics customers discontinue using all affected test kit lots identified as part of the recall and quarantine remaining inventory. On August 31, 2021, Magellan Diagnostics began notifying customers that the recall was expanded to include additional LeadCare II product lots. The recall now includes the majority of all test kits distributed since October 27, 2020. Product distribution has been paused until further notice, and replacement product is currently unavailable. It is unknown when replacement product will be available.
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