Magellan Diagnostics, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1925-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: November 29, 2014

Date Posted: May 24, 2017

Recall Number: Z-1925-2017

Event ID: 76991

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.

Status: Terminated

Product Quantity: 49 units

Code Information:

All serial numbers

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated