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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.

FDA Recall Z-0940-2021 · Posted None

Recalling FirmBiomeme, Inc.
Recall StatusTerminated
Product CodeQJR
Date Initiated2021-01-05
Date Terminated2021-06-11
Product Quantity147 systems

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

Domestic: FL, TX, IN, KY, OH, NY, CA, PA, MD. Foreign: Canada, Zimbabwe.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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