- Abbott has identified a software problem as the cause of false positives delivered by some of its COVID-19 laboratory tests.
- Work is underway to correct the software associated with Abbott's Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kits. FDA said laboratories that use the tests before their software is corrected should treat the results as presumptive and that they may need to be confirmed with another test.
- FDA assigned the recall to its highest risk category in light of the dangers of misdiagnosing someone with COVID-19. The correction of the software is subject to a Class I recall as use of these tests before the software update may cause serious adverse health consequences or death, according to the agency.
FDA alerted clinical laboratory staff and healthcare providers to the potential for the two Abbott tests to deliver false positives last month. At that time, FDA's discussion of the causes of the false positives centered on the potential for the mixing parameters to cause wells in the assay reagent tray to overflow, leading positive samples to contaminate negative specimens in neighboring wells.
The overflowing wells are still the focus of FDA's communications on the problem but the source of the issue has now been traced back to the software for the two COVID-19 test kits. The software automates the mixing of chemicals for the tests in the processing equipment used to prepare the samples.
FDA has identified 187 software installations that need to be corrected. Laboratories use the affected software to automate testing with the almost 10 million Alinity m SARS-CoV-2 Amp tests that Abbott has distributed in the U.S., as well as almost 50,000 Alinity m Resp-4-Plex AMP tests. The figures give an indication of the extent to which single-pathogen tests have outsold multiplex respiratory assays.
Abbott provides the tests to clinical laboratories. Curative is among the users of Abbott tests, having switched to the assays after FDA issued an alert about the risk of its own product giving false results, potentially because of issues around sample collection.
FDA is taking the false positives linked to the Abbott tests seriously enough to issue a Class I recall. The categorization of the software correction in the highest risk class reflects FDA's concerns about the potential for false results to delay the diagnosis of the actual cause of an illness, which could be life threatening. FDA also cited the dangers of unnecessary treatment for COVID-19.
For now, the risks remain theoretical. Currently, FDA knows of no deaths or adverse health consequences associated with the use of the two Abbott test kits.