Abbott Molecular is recalling select COVID-19 testing kits after the discovery of a potential false positive result, causing potential issues for patients.
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. The false positive results may be related to the current mixing parameters for the chemicals that are combined with patient samples to detect the viruses.
In some cases, the mixing parameters may cause a sample in one well of the machine’s tray to overflow into another sample well. Overflow into the wells of true negative samples that are positioned near positive samples in the tray could produce false positive results.
The official kits included in this recall are Alinity m SARS-CoV-2 AMP Kits and Alinity m Resp-4-Plex AMP Kits.
A false positive result for COVID-19 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 health care 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.