Blood Lead Collection Tube Shortage

On January 19, 2022, the Food and Drug Administration (FDA) updated the device shortage list to include all blood specimen collection tubes. 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. Refer to FDA’s Blood Specimen Collection Tube Shortage: Frequently Asked Questions for additional information.

CDC recommends the following actions to ensure children receive accurate blood lead tests.

• Communicate with testing laboratories about appropriate specimen requirements as these may change over time.
• Use blood collection tubes that have been manufactured specifically for trace element testing or pre-screened lead-testing tubes. Contamination in collection tubes can contribute to inaccurate results.
• If the recommended tubes are not available, discuss acceptable alternatives with testing laboratories.

Additional Resources

Food and Drug Administration (FDA)

• Medical Device Shortages During the COVID-19 Public Health Emergency
• UPDATE: Blood Specimen Collection Tube Conservation Strategies – Letter to Health Care and Laboratory Personnel
• Blood Specimen Collection Tube Shortage: Frequently Asked Questions

Association of Public Health Laboratories Webinar: The Importance of Lot Testing for Pediatric Lead Testing (000-634-19)

Clinical and Laboratories Standards Institute C40-A2 document: Measurement Procedures for the Determination of Lead Concentrations in Blood and Urine, 2nd Edition

Ward CD, Williams RJ, Mullenix K, Syhapanha K, Jones RL, Caldwell K. Trace Metals Screening Process of Devices Used for the Collection, Analysis, and Storage of Biological Specimens. At Spectrosc. 2018 Dec;39(6):219-228.