Vacutainer Brand Plus Tube with Edta Anticoagulant(Multiple)

• • Terminated Z-1140-2018 FDA Class I ·initiated 22 Mar 2018 ·on shared 510(k) K971449

  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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K971449 ↗

FDA Product Code

GIM

Device Class

Class II

Regulation

21 CFR Part 862.1675

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Becton Dickinson Vacutainer Systems →