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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top Tubes can cause an underestimation of lead in blood samples when used with Magellan Diagnostics LeadCare assays, employing the Anodic…"
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 1,116,012,050 units distributed in 46 states and Puerto Rico.
The FDA determined that 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 could lead to incorrect clinical results for patients being tested for lead exposure.
Healthcare facilities and laboratories should stop using the affected catalog numbers for lead testing with ASV-based assays. Consumers should contact their healthcare provider if they have had recent blood lead tests using these specific tubes to discuss the potential impact on their results.
The recalled product
- Product
- BD Vacutainer¿ EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401 (UDI: 50382903664011); 2. 366450 (UDI: 50382903664509); 3. 366643 (UDI: 50382903666435); 4. 367835 (UDI: 50382903678353); 5. 367841 (UDI: 50382903678414); 6. 367844 (UDI: 50382903678445); 7. 367856 (UDI…
- Manufacturer
- Becton Dickinson & Company
- Affected units
- 1,116,012,050
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 (15)
- All lots. Catalog Number (Shelf Life): 1. 366401 (24 months)
- 2. 366450 (24 months)
- 3. 366643 (12 months)
- 4. 367835 (16 months)
- 5. 367841 (15 months)
- 6. 367844 (16 months)
- 7. 367856 (16 months)
- 8. 367861 (16 months)
- 9. 367862 (16 months)
- 10. 367863 (17 months)
- 11. 368021 (16 months)
- 12. 368047 (15 months)
- 13. 368054 (16 months)
- 14. 368661 (17 months)
- 15. 364300 (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.
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