Magellan Diagnostics, Inc. recalls Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010

Recall date

November 29, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1926-2017

FDA classification

Class I

Brand / firm

Magellan Diagnostics, Inc.

Sold / distributed

Nationwide Distribution

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010