LeadCare blood lead tests recall expanded due to risk of falsely low results
The Food and Drug Administration and Magellan Diagnostics Inc. today expanded the ongoing recall of LeadCare II, LeadCare Plus and LeadCare Ultra Blood Lead Tests distributed between Oct. 27, 2020, and Aug. 19, 2021. FDA lists this as a Class I recall, the most serious type, due to a significant risk of falsely low results that could cause serious injuries, including in young children and pregnant individuals. FDA said clinicians should continue scheduled tests using other methods and retest children previously tested with a recalled kit. A replacement product is currently unavailable.
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