Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1925-2017 — Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010

U.S. FDA — Device Enforcement · United States · 2014-11-29 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1925-2017
Date of alert
2014-11-29
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Magellan Diagnostics, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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