The U.S. Food and Drug Administration (FDA) is aware the U.S. is experiencing significant interruptions in the supply of sodium citrate blood specimen collection tubes, also known as light blue top tubes (hereafter “sodium citrate tubes”), used for coagulation (blood clotting) testing because of an increase in demand and recent vendor supply challenges.
On June 10, 2021, the FDA added these tubes (product codes GIM and JKA, sodium citrate tubes only) to the section 506J device shortage list. The FDA has also provided conservation strategies for these tubes during the COVID-19 public health emergency.
The FDA recommends health care and laboratory facilities develop and implement conservation strategies to minimize the use of these tubes and maintain the quality and safety of care for patients who need coagulation testing.
On July 22, 2021, the FDA issued an Emergency Use Authorization (EUA) for specific sodium citrate tubes for emergency use in health care settings to collect, transport, and store blood specimens for coagulation testing to aid in the identification and treatment of coagulopathy in patients with known or suspected COVID-19, with testing performed by authorized laboratories.
Updates:
Q: What does it mean to be an “authorized laboratory” that can use tubes under this EUA?
A: Testing using these blood collection tubes is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. §263A), and that meet requirements to perform moderate and high complexity tests.
Q: Is there a shortage of sodium citrate (light blue top) tubes?
A: The FDA has determined that, based on available information, due to an increase in demand and recent vendor supply challenges, there is a shortage of sodium citrate (light blue top) tubes at this time, and added these devices (product codes GIM and JKA, sodium citrate tubes only) to the section 506J device shortage list on June 10, 2021. The device shortage list reflects the categories of devices the FDA has determined to be in shortage at this time, and the FDA will continue to update the list as the COVID-19 public health emergency evolves.
The FDA continues to monitor the current situation to help ensure that coagulation testing remains available for patients for whom such testing is medically necessary.
Q: Are sodium citrate (light blue top) tubes from different manufacturers interchangeable for coagulation testing?
A: Not necessarily. Draw and test specifications for certain tests may differ among sodium citrate tubes from different manufacturers thereby potentially altering the test results.
Trained staff should perform validation testing using established reagents and instruments before transitioning between tubes from different manufacturers. Furthermore, certain tube collection systems from other manufacturers may not work with your current collection system. Additional staff training may be necessary to use other blood collection tube systems.
Q: What is FDA doing to mitigate the supply challenges of sodium citrate (light blue top) tubes?
A: On July 22, 2021, to help with availability of sodium citrate tubes during the pandemic, the FDA issued an Emergency Use Authorization (EUA) for BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site) used to collect, transport and store blood samples for testing to aid in the identification and treatment of coagulopathy in patients with known or suspected COVID-19. Testing using these blood collection tubes is limited to authorized laboratories. For more information on these authorized tubes, please review the EUA authorization letter and accompanying Fact Sheet.
In addition, the FDA has provided recommendations for conservation strategies for use by health care organizations, laboratory facilities, and their personnel—categorized for a range of clinical needs and supply levels—to assist these groups in determining conservation procedures during this time period.
The FDA continues to work diligently to mitigate any supply chain shortages and is taking action to assure health care and laboratory personnel have sufficient supplies for coagulation testing.
