PlainRecalls
FDA Devices Low Class III Terminated

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.

Reported: February 10, 2021 Initiated: January 5, 2021 #Z-0940-2021

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.

Details

Recalling Firm
Biomeme, Inc.
Units Affected
147 systems
Distribution
Domestic: FL, TX, IN, KY, OH, NY, CA, PA, MD. Foreign: Canada, Zimbabwe.
Location
Philadelphia, PA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Biomeme, Inc.. Units affected: 147 systems.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 10, 2021. Severity: Low. Recall number: Z-0940-2021.

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