Recall – Software error leads to instrument failure in IVD systems

Company: Biomeme, Inc.
Date of Enforcement Report: 2/10/2021
Class III

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.

Recall Number: Z-0940-2021

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/MANUFACTURER

Biomeme, Inc. on 1/31/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

147 systems

DISTRIBUTION

U.S. Nationwide and International

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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