BD Vacutainer Tubes Recalled for Lead Test Inaccuracy
Becton Dickinson is recalling specific Vacutainer tubes because they may cause underestimation of lead levels in blood samples when used with certain assays.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class I, but the hazard is a diagnostic inaccuracy (underestimation of lead) rather than a direct physical injury or contamination, fitting the criteria for a moderate risk of adverse health consequences due to misdiagnosis.
Plain-English summary
Becton Dickinson & Company is recalling BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top Tubes. The recall involves 3,956,900 units distributed in 46 states and Puerto Rico.
The recall is issued because these tubes can cause an underestimation of lead in blood samples when used with Magellan Diagnostics LeadCare assays or any other assay employing Anodic Stripping Voltammetry (ASV) methodology. This inaccuracy may affect the reliability of lead level testing results.
Healthcare providers and laboratories should stop using these specific tubes for lead testing with ASV-based assays. Consumers who have had blood tests using these tubes should consult their healthcare provider regarding the potential impact on their results.
The recalled product
- Product
- BD Vacutainer¿ EDTA Tan Top Tube; Catalog Number: 367855 (UDI: 50382903678551)
- Manufacturer
- Becton Dickinson & Company
- Affected units
- 3,956,900
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Part of a larger recall action
This product is one of 4 recalled by Becton Dickinson & Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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