Abbott recalls software for COVID-19 lab tests

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CORRECTION: An earlier version of this story said it was the home testing kits that were being recalled. The correction was made to say that it was the lab testing software and not the home testing kits that were being recalled.

(ABC4)- Abbott Molecular is recalling two of its Alinity COVID-19 lab test kits due to potential false positive results.

The company is recalling its Alinity m SARS-CoV-2 AMP Kits and Alinity m Resp-4-Plex AMP Kits because they have the potential to issue false positive results when being used to detect the SARS-CoV-2, the virus that causes COVID-19.

The U.S. Food and Drug Administration (FDA) issued a similar notice on September 17 to clinical laboratory staff and health care providers regarding the Alinity testing kits. 

A “false positive” is a test result that indicates that a person has the virus when they do not actually have it. The false test result may be related to the current mixing parameters for the chemicals that are combined with patient samples to detect the viruses. 

Abbott said in a press release that in some cases, the mixing parameters may cause a sample in one well of the machine’s tray to overflow into another sample well during testing. Overflow into the wells of true negative samples that are positioned near positive samples in the tray could produce false positive results.

According to Abbott, 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 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.

So far, Abbott reports no deaths or adverse health consequences from use of the tests.

The company issued an Urgent Field Safety Notice/Field Correction Recall to everyone who used either of the Alinity tests. They request that an acknowledgement letter of  the notice of recall be completed and returned.

They, along with the FDA, said to consider all positive SARS-CoV-2 test results presumptive until the company can implement updated software specification files to correct the issue.

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