FDAFDA · Food and drugs·Recall number Z-1925-2017
Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
Published May 24, 2017 · Recall initiated: November 29, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Magellan Diagnostics, Inc.
- Distributor
- Nationwide Distribution
- Lot
- All serial numbers
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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