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# Magellan Diagnostics Recalls Lead Tests
- URL: https://www.fdaweb.com/magellan-diagnostics-recalls-lead-tests/
- Published: 2021-07-12T12:00:00.000Z
- Updated: 2026-09-14T17:05:51.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149684

Magellan Diagnostics has recalled its LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests due to a significant risk of false low results. “The FDA 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,” a [recall notice](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDIsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMTA3MTIuNDMwOTUzNDEiLCJ1cmwiOiJodHRwczovL3d3dy5mZGEuZ292L21lZGljYWwtZGV2aWNlcy9tZWRpY2FsLWRldmljZS1yZWNhbGxzL21hZ2VsbGFuLWRpYWdub3N0aWNzLXJlY2FsbHMtbGVhZGNhcmUtaWktbGVhZGNhcmUtcGx1cy1hbmQtbGVhZGNhcmUtdWx0cmEtYmxvb2QtbGVhZC10ZXN0cy1kdWUtcmlzaz91dG1fbWVkaXVtPWVtYWlsJnV0bV9zb3VyY2U9Z292ZGVsaXZlcnkifQ.VyaCNCRcN9EE%5FZK%5F1B6Dc6xz27D7Im-XUeVXnI9-biY/s/1255931999/br/109189998999-l?ref=fdaweb.com) says. False low results may lead to patient harm, including delayed puberty, reduced postnatal growth, decreased IQ, and inattention and behavior problems in children, it says.