![]() ![]() 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. ![]() 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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