CDC Health Update - Expansion of Recall of LeadCare Blood Lead Tests Due to Risk of Falsely Low Results

Published: 10/14/2021

Sources:
  • Centers for Disease Control and Prevention
Relevant To:
  • Urgent Care,
  • Medical Office,
  • Critical Access Hospitals,
  • Hospitals,
  • Ambulatory Care,
  • Clinical Lab,
  • Rural Health Clinics

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…

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