07/26/2021: Lab Advisory: FDA Authorizes Imported Becton Dickinson Sodium Citrate Blood Specimen Collection (Light Blue Top) Tubes

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals and Individuals Performing COVID-19 Testing

Level: Laboratory Advisory

On July 22, 2021, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to Becton, Dickinson and Company (BD) for its BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site), which are sodium citrate blood specimen collection tubes used to collect, transport, and store blood samples for coagulation testing. The device authorized under this EUA is for use in coagulation testing by CLIA-certified laboratories performing non-waived testing, to aid in the identification and treatment of coagulopathy in patients, including (but not limited to) patients with known or suspected COVID-19.

Refer to these frequently asked questions (FAQs) for more information about sodium citrate blood specimen collection tubes.

For questions, contact the FDA Division of Industry and Consumer Education (DICE).

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The Laboratory Outreach Communication System

Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)