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Recall Observatory FDA recall evidence

Device product

Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010

Z-1925-2017

November 29, 2014

Class I

Product summary

Firm
Magellan Diagnostics, Inc.
Event
Event 76991
Status
Terminated
Classification
Class I
Quantity
49 units
Official record key
device-enforcement:Z-1925-2017

Official wording

Reason: 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.

Code information: All serial numbers

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.