FDA MedWatch - COVID-19 Update: FDA Authorizes Imported Becton Dickinson Sodium Citrate Blood Specimen (Light Blue Top) Collection Tubes

U.S. Food and Drug Administration sent this bulletin at 07/22/2021 06:09 PM EDT

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

COVID-19 Update: FDA Authorizes Imported Becton Dickinson Sodium Citrate Blood Specimen (Light Blue Top) Collection Tubes

Today, the 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, performed by authorized laboratories, to aid in the identification and treatment of coagulopathy in patients with known or suspected COVID-19.

The FDA also posted frequently asked questions (FAQs) about sodium citrate blood specimen collection tubes.

For details on the EUA, see the letter of authorization (PDF).

Questions?

If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).

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