June 10, 2021

The U.S. Food and Drug Administration (FDA) is aware that the U.S. is experiencing significant interruptions in the supply of sodium citrate blood specimen collection (light blue top) tubes because of an increase in demand during the COVID-19 public health emergency and recent vendor supply challenges.

Recommendations

The FDA recommends that health care providers, laboratory directors, phlebotomists, and other personnel consider the following conservation strategies:

• Do not include sodium citrate (light blue top) tubes in routine collections of a variety of specimens at the time of other blood sampling or IV insertion.
• Do not use sodium citrate (light blue top) tubes unless medically necessary.
• Do not use sodium citrate (light blue top) tubes as discard tubes; consider clear top or red stopper (no additive) tubes as an alternative.
• Limit allocation of 1.8mL sodium citrate (light blue top) tubes for difficult blood collections.

The FDA also recommends health care and laboratory facilities develop and implement the above strategies to minimize the use of these tubes and maintain the quality and safety of care for patients for whom testing is medically necessary.

FDA Actions

On June 10, 2021, the FDA added these tubes (product codes GIM and JKA) to the section 506J of the Federal Food, Drug, and Cosmetic Act device shortage list during the COVID-19 public health emergency.

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 aid in the identification and treatment of coagulopathy in patients with known or suspected COVID-19.

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. The FDA will inform the public if significant new information becomes available.

The FDA carefully reviews each notification under section 506J of the Federal Food, Drug, and Cosmetic Act (or "506J notification") it receives, and uses this information, along with additional information on the supply and demand of the device, to determine whether a device is in shortage.

Reporting Problems to the FDA

The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with sodium citrate blood specimen collection (light blue top) tubes.

• 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 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.

In addition, the FDA is interested in hearing from health care facilities and providers experiencing difficulty obtaining devices, as well as from other stakeholders who may be able to help mitigate potential shortages. You may email the FDA at [email protected].

Contact Information

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