Z-0940-2021Class III

Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or...

Name: Z-0940-2021 Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or...
Creator: Biomeme, Inc.
Published: 2021-01-05
License: https://open.fda.gov/license/

Biomeme, Inc. / initiated 2021-01-05 / Terminated / root cause: software

FDA source

Biomeme, Inc. began a recall of 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... on 2021-01-05. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0940-2021
Classification: Class III
Status: Terminated
Initiated: 2021-01-05
Posted: 2021-02-01
Terminated: 2021-06-11
Recalling firm: Biomeme, Inc.
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.
Product code: QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 147 systems
Distribution: Domestic: FL, TX, IN, KY, OH, NY, CA, PA, MD. Foreign: Canada, Zimbabwe.
Product codes and lots: Device Reference/Catalog Number (Black) - 1000003, (white) - 1000018. Software version 6.4.3 EUA - Emergency Use Authorization

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0940-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0940-2021	Class III	Terminated	Voluntary: Firm initiated	2021-02-10	2021-01-31

Product code QJR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)