CLN - Federal Insider

BD Recalls Blood Collection Tubes That Contributed to Inaccurate Lead Test Results

Regulatory Roundup: May 2018

On March 22, Becton Dickinson (BD) issued a recall for more than 982 million venous blood collection tubes nationwide due to certain BD tubes chemically interfering with tests that use anodic stripping voltammetry (ASV). BD discovered this interference while working with the Food and Drug Administration (FDA) on the agency’s investigation into the cause of inaccurate results associated with Magellan’s LeadCare test systems, which are ASV-based tests. The specific tubes BD is recalling are the Vacutainer EDTA lavender, tan, and pink top tubes, as well as the Vacutainer lithium heparin green top tube. Studies conducted by BD found that the rubber stoppers of the recalled tubes contain a chemical called thiuram that can release sulfur-containing gases that dissolve into blood samples and bind tightly to lead particles, making it difficult for ASV-based tests like Magellan’s to detect the correct amount of lead in a sample. FDA has identified this as a class I recall, which means that use of these tubes may cause serious injuries or death. However, in FDA’s notice about the recall, the agency states that labs can continue to use the affected tubes with assays that do not use ASV methodology.

In addition, FDA continues to recommend against using Magellan lead tests with venous blood samples because other manufacturers may also use thiuram in their blood collection tubes. FDA is following up with other blood collection tube manufacturers serving the U.S. market to determine how widespread this problem might be. The agency is also continuing to evaluate other factors that may have contributed to inaccurate results observed with Magellan lead tests.