Home / Recalls / Medical Devices
Magellan Diagnostics, Inc. recalls Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
Recalled May 24, 2017 · FDA recall Z-1926-2017 · Magellan Diagnostics
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. · FDA Class I
Units
1016
Sold at
Nationwide Distribution
Description
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.
Product
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
Manufacturer(s)
Magellan Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →