Derived label

Device software or design

Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens. The RT-PCR test runs on a Franklin Real-Time PCR Thermocycler Device (Reference/Catalog Number 1000003,1000018) with the Software Controller version 6.4.3. The cycler has a "baseboard" unit with firmware and associated software component that control motorized movements of the optical filter carriage used for PCR detection.

reason.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: error in the software
Rule explanation: Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm: Biomeme, Inc.