Recall Z-0940-2021 ยท QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Biomeme, Inc.
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
| Date | Jan 5, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 147 systems |
| Distribution | Domestic: FL, TX, IN, KY, OH, NY, CA, PA, MD. Foreign: Canada, Zimbabwe. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.