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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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.
An investigation by FDA and BD has concluded that a chemical used in some test-tube stoppers is the reason for false results on some blood-based lead tests from Magellan Diagnostics.