BD Vacutainer Blood Collection Tubes by Becton, Dickinson and Company (BD): Class I Recall – Chemical Interference with Certain Tests

ISSUE: BD is recalling their Vacutainer EDTA Blood Collection Tubes with lavender, tan, pink and green rubber tube stoppers due to a chemical in the rubber tube stopper that interferes with the accuracy of the Anodic Stripping Voltammetry (ASV) testing methodology. ASV is the methodology used in Magellan Diagnostics’ LeadCare Testing Systems. The tube stoppers contain a substance called thiuram that can sometimes release sulfur-containing gases, which may dissolve into the blood sample and bind the lead particles. This chemical reaction makes it difficult for the Magellan lead tests to detect the correct amount of lead in the sample and may cause falsely lower test results. 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.

The tubes can continue to be used with other non-ASV blood lead level test technologies such as Graphite furnace atomic absorption spectroscopy (GFAAS) and Inductively Coupled Plasma Mass Spectrometry (ICP-MS) and other assays (non-lead) which do not use ASV methodology.

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