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.
This recall has been terminated (originally issued January 5, 2021).
- Company
- Biomeme, Inc.
- Recall Initiated
- January 5, 2021
- Terminated
- June 11, 2021
- Recall Number
- Z-0940-2021
- Quantity
- 147 systems
- Firm Location
- Philadelphia, PA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Domestic: FL, TX, IN, KY, OH, NY, CA, PA, MD. Foreign: Canada, Zimbabwe.
Lot / Code Info
Device Reference/Catalog Number (Black) - 1000003, (white) - 1000018. Software version 6.4.3 EUA - Emergency Use Authorization
Root Cause
Software design
Action Taken
On 01/05/2021 Biomeme, Inc., issued an Urgent Device Recall Correction for the latest build of the Franklin Real-Time PCR Thermocycler, which affects some devices built since September 21st, 2020. This software correction is to fix an issue where the device is unable to get past the beginning stages of the test.