Falsely Low Results Lead FDA To Affix Class I Designation To Recall Of Magellan Lead Tests
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.
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Several additional batches of Magellan’s LeadCare II tests are being recalled as efforts to address the root cause continue.
Common blood tests for lead poisoning manufactured by Magellan Diagnostics could give false low results if used with venous blood, FDA warned. About 8 million of the tests have been performed since 2014.
Device makers presented with an affidavit by the US FDA during a facility inspection should walk away as quickly as possible, King & Spalding partner Jessica Ringel advises.