FDA-Device2017-05-24Class I
Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
Magellan Diagnostics, Inc.
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.
Sold states
Nationwide Distribution
Affected count
49 units
Manufactured in
101 Billerica Ave Bldg 4, North Billerica, MA, United States
Products
Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1925-2017Don't want to check this manually?
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