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
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:
- 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
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)