Biomeme, Inc. - Biomeme SARSCoV2 RealTime RTPCR Test - Class 2 Recall

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 Biomeme s M1 Sample Prep Cartridge for RNA extraction, Biomeme s SARS-CoV-2 Go-Strips assay, and Biomeme s portable Franklin" Real-Time qPCR Thermocycler. Franklin s 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.
Source: Medical Device Recalls - Category: Medical Devices Source Type: alerts