Medical Device Safety and Recalls: Magellan Diagnostics Inc. Expands Recall for LeadCare Testing Systems Due to Inaccurate Test Results

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Magellan Diagnostics Inc. Expands Recall for LeadCare Testing Systems Due to Inaccurate Test Results

Magellan Diagnostics is expanding LeadCare Plus and Ultra Testing Systems recall to include two additional testing systems; LeadCare and LeadCare II Blood Lead Testing Systems.

Magellan Diagnostics is recalling the LeadCare and the LeadCare II Testing Systems because they may underestimate the blood lead levels (BLL) and give inaccurate results when processing venous blood samples. Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning. The use of affected product may cause serious adverse health consequences.

This recall accompanies FDA's safety communication from May 17, 2017. Magellan's LeadCare and LeadCare II Testing Systems are two of four blood lead testing systems affected by the recommendations in FDA's safety communication.

The FDA is unable to identify the root cause for the inaccurate results, based on data provided by Magellan. We are conducting studies with the Center for Disease Control and Prevention (CDC) to identify the cause and better characterize the extent of the problem.

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