Biomeme, Inc. Recall 87153
Description: 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.
Biomeme, Inc. Recall 87153 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0940-2021 |
| Event ID | 87153 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | Domestic: FL, TX, IN, KY, OH, NY, CA, PA, MD. Foreign: Canada, Zimbabwe. |
| Quantity | 147 systems |
| Recall 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. |
| Device Classification | 20210210 |
| Device Code Info | Device Reference/Catalog Number (Black) - 1000003, (white) - 1000018. Software version 6.4.3 EUA - Emergency Use Authorization |
| Center Classification Date | 20210131 |
| Recall Initiation Date | 20210105 |
| Recalling Firm | Biomeme, Inc. |
| Initial Notification | |
| Similar To |