Z-0940-2021 Class III Terminated
FDA device recall Z-0940-2021 was initiated by Biomeme, Inc. on January 5, 2021 and is designated Class III. 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. The recall status is terminated (terminated June 11, 2021). Affected quantity: 147 systems.
Recall Details
- Product Type
- Devices
- Report Date
- February 10, 2021
- Initiation Date
- January 5, 2021
- Termination Date
- June 11, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 147 systems
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.
Distribution Pattern
Domestic: FL, TX, IN, KY, OH, NY, CA, PA, MD. Foreign: Canada, Zimbabwe.
Code Information
Device Reference/Catalog Number (Black) - 1000003, (white) - 1000018. Software version 6.4.3 EUA - Emergency Use Authorization