Expansion of recall of blood lead tests to assess lead levels

Oct. 15, 2021

The Centers for Disease Control and Prevention (CDC) has issued a safety alert about the expansion of Magellan Diagnostics’ recall of LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests.

The tests 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 CDC said. The use of these devices may cause serious injuries because they might underestimate blood lead levels. The CDC said that the FDA has identified this as a Class I recall, the most serious type of recall.

The safety alert from the Health Alert Network (HAN) updates a notice the CDC issued on July 6.

The issue of falsely low results is particularly problematic for vulnerable patients. For example, “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,” the CDC said.

FDA initially notified CDC on June 24, 2021, that some Magellan Diagnostics blood lead test kits were undergoing a voluntary recall by the manufacturer. The 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, the CDC explained.

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