09/17/2021
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.
Please share this message with your networks and invite them to opt in to LOCS to receive future updates.
Online resources:
Information for Laboratories about Coronavirus (COVID-19)
Frequently Asked Questions about Coronavirus (COVID-19) for Laboratories
CDC Coronavirus (COVID-19) Website
CDC Laboratory Outreach Communication System (LOCS)
Clinical Laboratory COVID-19 Response Calls
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
