FDA Device recall Z-0940-2021
Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infect…
- FDA Device
- Class III
- terminated
- Published 2021-02-10
On 2021-02-10 the FDA classified a Class III recall of Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infect… by Biomeme, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0940-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-01-05 |
| Published | 2021-02-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biomeme |
| Distribution | CA, FL, IN, KY, MD, NY, OH, PA, TX |
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.
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.
Identifiers
| code_info | Device Reference/Catalog Number (Black) - 1000003, (white) - 1000018. Software version 6.4.3 EUA - Emergency Use Authorization |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0940-2021%22
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