Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
FDA Recall #Z-1925-2017 — Class I — November 29, 2014
Product Description
Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
Reason for Recall
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.
Recalling Firm
Magellan Diagnostics, Inc. — North Billerica, MA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
49 units
Distribution
Nationwide Distribution
Code Information
All serial numbers
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated