09/17/2021: Lab Alert: FDA Issues Letter about Potential False Positive Results with Abbott Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Individuals Performing COVID-19 Testing

Level: Laboratory Alert

On September 17, 2021, the U.S. Food and Drug Administration (FDA) issued a Letter to Clinical Laboratory Staff and Health Care Providers about false positive results that can occur with the Abbott Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits.

This letter includes important information about the Abbott Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits, including:

  • Details on potential false positive results
  • Recommendations for clinical laboratory staff and health care professionals
  • Actions the FDA is taking
  • Instructions for reporting problems with the Alinity m SARS-CoV-2 AMP or Alinity m Resp-4-Plex AMP Kits

For questions about this letter, email COVID19DX@fda.hhs.gov.

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Online resources:

Questions?  

  • If you are a clinical or public health laboratory professional, contact LOCS.
  • For media inquiries, contact the CDC Newsroom.
  • For all other questions, contact CDC-INFO.

Thank you,

The Laboratory Outreach Communication System

Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)

LOCS@cdc.gov

www.cdc.gov/csels/dls/locs

Page last reviewed: September 17, 2021