Update: The recalled product is the software for Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit. The kits can continue to be used after the software has been updated. If used before the software correction, positive results should be treated as presumptive, which means results may need to be confirmed with another test.
Abbott Molecular, Inc. is recalling Alinity m SARS-CoV-2 AMP Kits and Alinity m Resp-4-Plex AMP Kits because they have the potential to give false positive results when 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. The recall described in this notice is due to the same issue that was announced in the September 17, 2021 Letter to Health Care Providers: Potential for False Positive Results with Abbott Molecular Inc. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these tests may cause serious adverse health consequences or death.