Magellan Diagnosticsis is recalling its LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests due to a significant risk of falsely low results.
The U.S. Food and Drug Administration (FDA), which has identified this as a Class I recall, said it “has significant concerns that the performance of the test may provide falsely low results and may lead to health risks in special populations such as young children and pregnant individuals.”
The FDA said on May 28, 2021, Magellan notified distributors through phone calls and on June 7, 2021 sent customers an Urgent Medical Device Recall letter requesting product removal of specific lots. On June 23, 2021, Magellan notified customers by phone the recall has been expanded to include additional lots.
According to the FDA, Magellan said that three lots of test kits not impacted by this recall. These are LeadCare II lots 2012M, 2018M, and 2102M.
The FDA said labs should discontinue use of all test kit lots identified as part of the recall and quarantine remaining inventory. They also should evaluate patient test results that were generated with the impacted lots and confirm suspect results with an alternative lead testing option, such as those using inductively coupled mass spectrometry or graphite furnace atomic absorption spectrometry at a high complexity, CLIA-certified, reference laboratory.
