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The U.S. Food and Drug Administration (FDA) is aware the United States is experiencing significant interruptions in the supply of several blood specimen collection (blood draw) tubes because of an increase in demand during the COVID-19 public health emergency and recent vendor supply challenges. The FDA is expanding the medical device shortage list to include all blood specimen collection tubes. The FDA previously issued a letter to health care and laboratory personnel on June 10, 2021, about a shortage of sodium citrate blood specimen collection (light blue top) tubes. 

The FDA recommends health care providers, laboratory directors, phlebotomists, and other personnel consider the following conservation strategies to minimize blood collection tube use and maintain quality and safety of patient care:

On January 19, 2022, the FDA updated the medical device shortage list to include all blood specimen collection tubes (product codes GIM and JKA). Section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires the FDA to maintain a publicly-available, up-to-date list of the devices the FDA has determined to be in shortage.

The FDA continues to monitor the current situation to help ensure blood testing remains available for patients where testing is medically necessary. The FDA will inform the public if significant new information becomes available.

The FDA reviews each notification received under section 506J and uses this information, along with any additional details about the supply and demand of a device, to determine whether a device is in shortage.

The FDA encourages health care providers to report all adverse events or suspected adverse events experienced with any blood specimen collection tube.

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

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 deviceshortages@fda.hhs.gov. Note that pursuant to section 506J manufacturers must notify the FDA of an interruption or permanent discontinuance in manufacturing of these devices.

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