FDANovember 29, 2014device
Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system.
What to do
FDA enforcement status: Terminated
Brands named
magellan diagnosticsmagellan
Recall history
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