Date: 02/09/2021
Software for Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit
Product Codes and Lot Numbers: See Medical Device Recall Database Entries below in the Additional Resources section.
Devices Recalled in the United States: 187 software installations are being corrected. 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). The kits can continue to be used following the implementation of the software correction. If used before the software correction, positive results should be treated as presumptive.
Distribution Date: May 13, 2020 to August 31, 2021
Date Initiated by Firm: September 2, 2021