On July 1, 2021, the U.S. Food and Drug Administration (FDA) issued a notice that Magellan Diagnostics, Inc., is recalling its LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests due to a significant risk of falsely low results. FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries.
– Centers for Disease Control and Prevention July 6, 2021
If your facility is using any of these test kits, it is recommended to discontinue use immediately. Please read the full notice below for more information: