Recall Z-0940-2021— Biomeme, Inc.
Class III · Terminated
Class III FDA medical device recall by Biomeme, Inc., initiated 2021-01-05, terminated 2021-06-11. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Biomeme, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2021-01-05
- Terminated
- 2021-06-11
- Firm location
- Philadelphia, PA, United States
Product 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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.