The special processing equipment uses software to automate the mixing of the chemicals for the tests. Samples for both tests are taken at a health care setting and require special laboratory processing equipment to get results. The test uses swab samples taken from the back of the nose and throat (nasopharyngeal) or the back of the mouth and throat (oropharyngeal) or by a procedure that washes the lungs with saline to collect a sample (bronchoalveolar lavage) of people suspected to have an illness caused by the COVID-19 virus. The Alinity m SARS-CoV-2 Assay and the Alinity m Resp-4-Plex are laboratory tests used to detect RNA of SARS-CoV-2-the virus that causes COVID-19. Date Initiated by Firm: September 2, 2021.If used before the software correction, positive results should be treated as presumptive. The kits can continue to be used following the implementation of the software correction. This software is used to automate testing with the 9,964,224 distributed tests for Alinity m SARS-CoV-2 Amp Kit (51,897 kits) and 48,192 distributed tests for Alinity m Resp-4-Plex AMP Kit (251 kits). Devices Recalled in the United States: 187 software installations are being corrected.Product Codes and Lot Numbers: See Medical Device Recall Database Entries below in the Additional Resources section.Software for Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit.Use of these devices may cause serious adverse health consequences or death. The FDA has identified this as a Class I recall, the most serious type of recall. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits. 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. October 15, 2021, Update: The FDA updated this recall classification notice to clarify that the potential for false positive results is due to the software associated with the Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kits, and the associated recall is to correct the software.
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