Becton Dickinson & Company: 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 Stripping Voltammetry (ASV) methodology, or any other assay employing ASV methodology.

Agency Publication Date: March 22, 2018

Affected Products

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: 50382903678568); 8. 367861 (UDI: 50382903678612); 9. 367862 (UDI: 50382903678629); 10. 367863 (UDI: 50382903678636); 11. 368021 (UDI: 50382903680219); 12. 368047 (UDI: 50382903680479); 13. 368054 (UDI: 50382903680547); 14. 368661

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)

Product: BD Vacutainer¿ EDTA Tan Top Tube; Catalog Number: 367855 (UDI: 50382903678551)

All lots

Product: BD Vacutainer¿ EDTA Pink Top Tube; Catalog Numbers: 1. 367842 (UDI: 50382903678421); 2. 367899 (UDI: 50382903678995); 3. 368049 (UDI: 50382903680493); 4. 368589 (UDI: 50382903685894)

All lots. Catalog Number (Shelf Life): 1. 367842 (Requested); 2. 367899 (Requested); 3. 368049 (Requested); 4. 368589 (Requested)

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)

All lots. Catalog Number (Shelf Life): 1. 366664 (Requested); 2. 367884 (Requested); 3. 367886 (Requested); 4. 368040 (Requested); 5. 366667 (Requested); 6. 367880 (Requested)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79223

Status: Resolved

Manufacturer: Becton Dickinson & Company

Manufactured In: United States

Units Affected: 4 products (1,116,012,050; 3,956,900; 64,784,900; 117,816,603)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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