Abbott has recalled two of its Alinity COVID-19 test kits after finding they can yield false positive results.
Abbott is recalling its Alinity m SARS-CoV-2 AMP kit and Alinity m Resp-4-Plex AMP kit, which use swab samples taken from the nose, mouth and throat to test for COVID-19, according to an Oct. 14 news release. The tests are administered in healthcare settings and must be sent to a lab for results. The FDA warned COVID-19 test labs last month that the test kits may be faulty.
The tests require lab equipment that uses software to automate the mixing of the chemicals. Abbott said an error in the software may cause a test sample in one well of the machine's tray to overflow into another test sample, which could cause a false positive result.
Abbott said it is working on fixing the software issue at each lab site where the tests are processed.
The FDA has classified the recall as Class I, the most serious type of recall, meaning use of the device could cause serious injury or death. Abbott said it has not received any reports of adverse events related to the test.
Read the full news release here.