US FDA, CDC Warn Of False Results On Lead Blood Tests
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.
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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 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.