Last week BD announced a Class I recall of its Vacutainer EDTA Blood Collection Tubes with lavender, tan, pink and green rubber tube stoppers. A chemical in the stopper interferes with the accuracy of the Anodic Stripping Voltammetry (ASV) testing methodology (used in Magellan Diagnostics’ LeadCare Testing Systems). Last week BD sent an Urgent Medical Device Correction Notice to affected customers and distributors.
The Vacutainer blood collection tubes are used to collect blood samples from a vein and are then transported to a clinical lab where the blood samples are processed.
More than 982 million devices (manufacturing dates March 29, 2016 to present) have been recalled nationwide.
“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.” – FDA
The tubes can be used with non-ASV blood lead level test technologies.