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- FDA Authorizes Imported ‘Blue-Top’ Tubes to Address National Shortage
On July 22, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to import and increase the supply of “blue-top” test tubes. The FDA action came after the CAP raised the shortage to the Department of Health and Human Services (HHS) in June. The CAP also issued initial guidance to pathologists and laboratory professionals on the blue-top tubes shortage and reviewed them with the FDA.
The FDA issued the EUA to Becton, Dickinson, and Company (BD) for its BD Vacutainer Plus Citrate Plasma Tubes manufactured at a facility in the United Kingdom. The device authorized under this EUA is for use in coagulation testing performed by authorized laboratories to identify and treat coagulopathy in patients with known or suspected COVID-19. Pathologists nationwide reported critical blue top shortages in their laboratories. The FDA released guidance on the blue tops shortage and conservation strategies for pathologists and laboratory professionals in the interim.
Acting FDA Commissioner Thanks CAP for Efforts to Address Pandemic
In June, the CAP reviewed with the officials from the FDA the recommendations developed by the CAP to address the shortage of blue-top tubes, which is expected to last throughout 2021. The CAP also had written the Department of Health and Human Services, the parent agency of the FDA, about the shortages.
In a follow-up letter to the CAP, FDA Acting Commissioner Janet Woodcock, MD, wrote to CAP President Patrick Godbey, MD, FCAP regarding its steps to solve the shortage.
“The Biden-Harris Administration is committed to addressing supply chain shortages caused by the COVID-19 pandemic,” Dr. Woodcock said. “Thank you again for your letter, your partnership, and the actions you and your colleagues at the College of American Pathologists are taking to help respond to the COVID-19 pandemic.”
The FDA has posted frequently asked questions (FAQs) about sodium citrate blood specimen collection tubes.