The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplification technology. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test contains primers and probes and internal controls used in RT-PCR for the in vitro qualitative detection of SARS-CoV-2 RNA in upper respiratory specimens. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test utilizes Biomemes M1 Sample Prep Cartridge for RNA extraction, Biomemes SARS-CoV-2 Go-Strips assay, and Biomemes portable Franklin" Real-Time qPCR Thermocycler. Franklins companion mobile app, Biomeme Go, scans tests, runs PCR experiments online or offline, and is used to quickly interpret your test results while conveniently syncing data to the Biomeme Cloud. Biomeme: 1000013 (Android Smartphone w/ Biomeme Go Mobile App) and Biomeme: 1000012 (Rugged Android Smartphone w/ Biomeme Go Mobile App) are controller for Biomeme Franklin thermocycler.

The firm has become aware of nine reports by a single customer that the software made false positive calls. The investigation determined that the root cause is the higher than expected amber-to-red co-excitation in the assay.

On 10/23/2020, the firm pushed the protocol update and the customer who initiated the complaint was notified. All other customers were informed of the update via email on 10/27/2020. Customers were told that the firm had deployed a change to their data processing algorithm specific to the SARS-CoV-2 protocol, which comprised of increasing the value of the co-excitation filter. Instruction to Customers: If your phone is not connected to the internet via wifi or cellular network, please connect the phone and login to the Biomeme Go app. The update will sync automatically to the Biomeme Go app and requires no further action if the phone running the Biomeme Go app is connected to wifi or a cellular network. The Before Fix Revision is 2020-03-24. The After Fix Revision is 2020-10-23. The firm also emphasized the importance to manually reviewing all results in the app or on the Biomeme Cloud. Should your PCR curves look at all suspect, contact the firm at [email protected]. All positive samples should be rerun.