Expansion of Recall of LeadCare Blood Lead Tests Due to Risk of Falsely Low Results
Magellan Diagnostics' recall of blood lead tests, first announced early this summer, has widened to include more product lots. The Class I event—the most serious type of recall—now encompasses nearly all test kits distributed since October 27, 2020, under the LeadCare II, LeadCare Plus, and LeadCare Ultra brands. The products pose a major risk of falsely low blood lead readings, which could lead to grave injuries. FDA is especially concerned about the threat to expecting mothers as well as the potential harms to developing babies and young children, including reduced postnatal growth, decreased IQ, attention and behavior problems, and delayed puberty. Magellan has halted distribution until further notice, and no replacement product is available currently. In light of the ensuing shortage of test kits, FDA recommends that clinicians continue to perform required blood lead tests, using inductively coupled plasma mass spectrometry or graphite furnace atomic absorption spectroscopy to analyze venous or capillary blood samples. They also should re-test children who were previously screened with recalled LeadCare kits and produced results below CDC's blood lead reference value.
Read more on the CDC Health Alert Network.