The U.S. Food and Drug Administration (FDA) is aware the United States is experiencing significant interruptions in the supply of blood specimen collection (blood draw) tubes because of an increase in demand during the COVID-19 public health emergency and recent vendor supply challenges.
On January 19, 2022, the FDA updated the device shortage list to include all blood specimen collection tubes (product codes GIM and JKA). Previously, on June 10, 2021, the FDA added only sodium citrate (light blue top) tubes to the device shortage list.
The FDA recommends health care providers, laboratory directors, phlebotomists, and other personnel consider blood specimen collection tube conservation strategies to minimize blood collection tube use and maintain quality and safe patient care for those where testing is medically necessary.
Q: Are all blood specimen collection tubes in shortage?
A: Yes, blood specimen collection tubes are in shortage, including sodium citrate tubes.
Based on available information, the FDA determined several types of blood specimen collection tubes are in shortage because of an increase in demand and recent vendor supply challenges. All of these tubes are covered under product codes GIM and JKA and were added to the section 506J device shortage list.
The device shortage list reflects the types of devices the FDA determined to be in shortage. The FDA will continue to update the list as needed.
The FDA continues to monitor the current situation to help ensure blood collection remains available for patients where testing is medically necessary.
Q: Are same color tubes from different manufacturers interchangeable for blood specimen collection and testing?
A: Not necessarily. Draw and test specifications for certain tests may differ among blood collection tubes from different manufacturers, potentially altering test results.
Trained staff should perform validation testing using established reagents and instruments before transitioning between tubes from different manufacturers. 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 the FDA doing to mitigate the supply challenges of blood specimen collection tubes?
A: The FDA recommends health care providers, laboratory directors, phlebotomists, and other personnel to consider blood specimen collection tube conservation strategies to minimize blood collection tube use and maintain quality and safe patient care for those where testing is medically necessary.
On July 22, 2021, the FDA issued an Emergency Use Authorization (EUA) to Becton Dickinson for certain sodium citrate blood specimen (light blue top) collection tubes used to collect, transport, and store blood samples for coagulation testing to better identify and treat 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.
The FDA continues to monitor the current situation to help mitigate supply chain shortages and take action to ensure health care and laboratory personnel have sufficient supplies for blood collection.
Q: What does it mean to be an “authorized laboratory” that can use EUA authorized sodium citrate blood specimen (light blue top) collection tubes under this EUA (Emergency Use Authorization (EUA) to Becton Dickinson)?
A: Testing that uses these sodium citrate blood specimen (light blue top) collection tubes is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. §263A) and that have met the requirements to perform moderate and high complexity tests.
Q: Can blood specimen collection tubes that are not FDA-cleared or authorized in the United States be used during the COVID-19 pandemic?
A: No. Any blood specimen collection tube that is not FDA-cleared or does not have an EUA under section 564(c) of the FD&C Act is not a legally marketed device and should not be used.
Q: Can we use expired blood tubes for patient specimen collection?
A: Expired blood tubes should not be used for patient specimen collection. Expired tubes should be discarded because out-of-date tubes may have decreased vacuum (preventing a proper fill) or degraded additives. Underfill of the specimen collection tube can result in inaccurate test results.
Q: My health care organization already has a plan for how we will handle the supply availability challenges for blood specimen collection tubes. Are we required to follow the FDA's recommendations listed in the letter to health care providers?
A: While you are not required to follow the FDA’s recommendations, the letter to health care providers is intended to help facilities manage supply challenges related to blood specimen collection tubes. The FDA's recommendations in the letter, as well as the FDA’s recommended conservation strategies, are suggestions that can help supplement health care organizations’ and laboratories’ current conservation strategies.
Q: What can I do if I have concerns about my health care organization’s supply of blood specimen collection tubes?
A: The FDA encourages health care providers to review and implement conservation strategies. If your conservation strategies are not adequate to maintain an adequate supply of tubes, the FDA encourages you to contact your group purchasing organization (GPO), local product representative, or account manager.
In addition, the FDA would like to hear from health care providers who have trouble obtaining devices, as well as from other stakeholders who may help mitigate potential shortages. You may email the FDA at [email protected].
Q: How do I report problems to the FDA?
A: The FDA encourages health care personnel to report all adverse events or suspected adverse events experienced with any blood specimen collection tube.
- Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
- Health care and laboratory personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. Note that pursuant to section 506J of the FD&C Act manufacturers must notify the FDA of an interruption or permanent discontinuance in manufacturing of these devices.
Additional FDA Resources:
To identify FDA-cleared blood specimen collection tubes, search the 510(k) Premarket Notification database using the product codes GIM and JKA.
To identify sodium citrate tubes with Emergency Use Authorization, see BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site).
For manufacturers to alert the FDA about supply chain issues, visit Contact the FDA About a Medical Device Supply Chain Issue.
For health care providers who have trouble obtaining devices, you may email the FDA at [email protected].
For additional information or questions about a medical device topic, contact FDA's Division of Industry and Consumer Education (DICE).