10

Feb

2021

Recall – Software error leads to instrument failure in IVD systems

recall, softwareerror

0

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

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