FDA-Device2018-03-28Class I

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

Becton Dickinson & Company

Hazard

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.

Sold states

Distributed in 46 states: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and Puerto Rico.

Affected count

1,116,012,050

Manufactured in

1 Becton Dr, N/A, Franklin Lakes, NJ, United States

Products

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 (UDI: 50382903686617); 15. 364300 (UDI: pre-UDI)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1139-2018

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