FDA: Class I recall of BD Vacutainer® blood collection tubes

Author's Note

The Food & Drug Administration on March 23 announced the Class I recall of Becton Dickinson (BD) Vacutainer® EDTA (ethylenediaminetetraacetic acid) blood collection tubes with lavender, tan, pink, and green rubber tube stoppers. Class I recalls are the most serious.

The recall was initiated because of a chemical in the tube stopper that interferes with the accuracy of the Anodic Stripping Voltammetry (ASV) testing methodology, which is the methodology used in Magellan Diagnostics’ LeadCare Testing Systems.

The 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.

The tubes can continue to be used with non-ASV blood lead level test technologies.

Vacutainer® (and/or Microtainer®) is a registered trademark of Becton, Dickinson and Company.