The FDA has updated the Abbott Molecular, Inc recall classification notice to clarify that the potential for false positive results is due to the software associated with the Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kits, and the associated recall is to correct the software. The kits can continue to be used following the implementation of the software correction. If used before the software correction, positive results should be treated as presumptive.
Abbott Molecular, Inc. is recalling the software for the Alinity m SARS-CoV-2 AMP Kits and Alinity m Resp-4-Plex AMP Kits because of the potential to issue false positive results when being used to detect SARS-CoV-2. For these tests, a “false positive” is a test result that indicates that a person has the virus when they do not actually have it.
A false positive result for SARS-CoV-2 could lead to:
- Delayed diagnosis or treatment for the actual cause of the person’s illness, which could be another life-threatening disease that is not COVID-19.
- Further spread of the SARS-CoV-2 virus when presumed positive people are grouped into cohorts (that is, they are housed together) based on false test results.
- The person receiving unnecessary COVID-19 treatment from a healthcare provider, such as antiviral treatment, convalescent plasma, or monoclonal antibody treatment, which can result in side effects.
- People not taking recommended precautionary measures against COVID-19, including vaccination.
- Isolation measures, including monitoring of household or other close contacts for symptoms, limiting contact with family or friends, and missing school or work.
- There have been no deaths or adverse health consequences reported from use of this test.
Who may be affected:
- People who received a positive test result for SARS-CoV-2 detected by Alinity m SARS-CoV-2 Assay or Alinity m Resp-4-Plex Assay
- Clinical laboratory staff and health care providers who have tested patient samples for SARS-CoV-2 using Alinity m SARS-CoV-2 Assay or Alinity m Resp-4-Plex