Biomeme, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0940-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: January 5, 2021

Date Posted: February 10, 2021

Recall Number: Z-0940-2021

Event ID: 87153

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.

Status: Terminated

Product Quantity: 147 systems

Code Information:

Device Reference/Catalog Number (Black) - 1000003, (white) - 1000018. Software version 6.4.3 EUA - Emergency Use Authorization

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated