Magellan Lead Test Recall Expanded After First Attempted Fix Found Insufficient
Several additional batches of Magellan’s LeadCare II tests are being recalled as efforts to address the root cause continue.
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It’s the third expansion for a high-risk class I recall of LeadCare II, LeadCare Plus and LeadCare Ultra Blood Lead Tests.
The US FDA issued three device-related close-out letters in August.
The LeadCare II, LeadCare Plus and LeadCare Ultra Blood Lead Tests made by Magellan Diagnostics Inc. were recalled because falsely low results could cause health risks to children and pregnant people.