FDA Statement on Findings from Ongoing Investigation into Magellan Diagnostics Lead Test Issues

Update from The U.S. Food and Drug Administration (FDA) on findings from ongoing investigation into the Magellan Diagnostics LeadCare Testing lead testing issues.

Today, the U.S. Food and Drug Administration (FDA) updated the Magellan Diagnostics LeadCare Testing Systems webpage, and released a statement from FDA’s Donald St. Pierre on findings from ongoing investigation into lead testing issues.

Based on data provided by Becton Dickinson & Company (BD), the FDA has concluded that one of the contributing factors to the inaccurate LeadCare test results is the chemical composition of the rubber stoppers of certain blood collection tubes.

Upon FDA’s request, BD conducted studies to assess the accuracy of Magellan’s LeadCare testing systems when used with venous blood collected into BD venous blood tubes. The FDA concluded that the studies performed by BD were robust and showed that there was a significant chance of incorrect results with Magellan’s LeadCare tests when used with venous whole blood collected in certain BD blood tubes. Upon further investigation, BD determined that the affected tubes’ rubber stoppers contain a chemical called thiuram that can release reactive gases, carbon disulfide (CS2) and carbonyl sulfide (COS), which can dissolve into the blood sample and bind tightly to lead particles. This chemical reaction makes it difficult for the Magellan lead tests to detect the correct amount of lead in the sample.

There are several BD blood collection tubes that contain thiuram and that could be used with the Magellan lead tests including the BD Vacutainer® EDTA Lavender Top, Tan Top, Pink Top tubes and BD Vacutainer® Lithium Heparin Green Top tubes. At FDA’s request, BD is conducting testing to determine whether clinical laboratory tests other than the Magellan lead tests are affected by the thiuram chemical interference. Based on the results of BD’s studies to date and our understanding of the mechanism of the interference, the FDA does not believe there is evidence showing that other clinical laboratory test results are impacted by the thiuram chemical interference at this time. BD is notifying their customers about this information.

Thiuram may be used by manufacturers other than BD to manufacture rubber stoppers for blood collection. The FDA is following up with manufacturers of blood tubes marketed in the U.S. to investigate this issue. The FDA continues to recommend that venous samples not be used with Magellan lead tests. This recommendation applies to all venous blood collection tubes. Capillary blood may continue to be tested with the Magellan lead tests.

The agency is still aggressively investigating this issue, including reviewing data from investigations performed by Magellan Diagnostics and BD, requesting additional information from relevant manufacturers regarding the issue, performing inspections as needed, and having additional independent studies performed.  We will continue to update the public with critical information as necessary.

This message is being broadcast by the Division of Communications in FDA’s Office of Regulatory Affairs (ORA).