Device product
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.
Z-0940-2021
Product summary
- Firm
- Biomeme, Inc.
- Event
- Event 87153
- Status
- Terminated
- Classification
- Class III
- Quantity
- 147 systems
- Official record key
device-enforcement:Z-0940-2021
Official wording
Reason: Users cannot complete testing due to a sign-error in the software component that controls the filter movement and results in an instrument failure and assay failure before results are generated.
Code information: Device Reference/Catalog Number (Black) - 1000003, (white) - 1000018. Software version 6.4.3 EUA - Emergency Use Authorization
Distribution pattern: Domestic: FL, TX, IN, KY, OH, NY, CA, PA, MD. Foreign: Canada, Zimbabwe.
Derived failure modes
-
Device software or design
error in the software
-
Potency or specification failure
assay failure