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: This is a Class I recall involving a diagnostic inaccuracy (underestimation of lead) without reported injuries or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Becton Dickinson & Company is recalling BD Vacutainer Lithium Heparin Green Top Tubes and BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes. The recall involves 117,816,603 units distributed across 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 testing results.
Healthcare providers and laboratories should stop using the affected 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¿ Lithium Heparin Green Top Tube; Catalog Numbers: 1. 366664 (UDI: 50382903666640); 2. 367884 (UDI: 50382903678841); 3. 367886 (UDI: 50382903678865); 4. 368040 (UDI: 50382903680400); 5. 366667 (UDI: 50382903666671); 6. 367880 (UDI: 50382903678803)
- Manufacturer
- Becton Dickinson & Company
- Hazard
- Affected units
- 117,816,603
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 (6)
- All lots. Catalog Number (Shelf Life): 1. 366664 (Requested)
- 2. 367884 (Requested)
- 3. 367886 (Requested)
- 4. 368040 (Requested)
- 5. 366667 (Requested)
- 6. 367880 (Requested)
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.
See all 4 products in this recall →Related recalls
Same manufacturer · Becton Dickinson & Company
See all →- SevereBD Quincke spinal trays recalled over Huons bupivacaine quality issues
FDA (Devices) · 2026-06-10
- SevereBD Whitacre 24 gauge spinal trays recalled over bupivacaine quality issues
FDA (Devices) · 2026-06-10
- SevereBD Whitacre 22G spinal trays recalled in Huons bupivacaine sub-recall
FDA (Devices) · 2026-06-10
- SevereBD Whitacre spinal trays across nine catalog numbers recalled over bupivacaine
FDA (Devices) · 2026-06-10
- SevereBD spinal trays recalled as a sub-recall of Huons bupivacaine
FDA (Devices) · 2026-06-10
Same hazard · diagnostic inaccuracy
See all →- High
- HighAtellica CH Enzymatic Hemoglobin A1c assay well-to-well bias
FDA (Devices) · 2026-07-15
- HighTBS iNsight bone density software calculation variability on Hologic machines
FDA (Devices) · 2025-03-12
- HighBD PCR Cartridges for MAX System signal drift in select lots
FDA (Devices) · 2025-01-29
- HighHPV-16 Diagnostic Probe Recalled for Suboptimal DNA Hybridization
FDA (Devices) · 2024-12-04