Z-0513-2021Class II

The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely...

Name: Z-0513-2021 The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely...
Creator: Biomeme, Inc.
Published: 2020-10-23
License: https://open.fda.gov/license/

Biomeme, Inc. / initiated 2020-10-23 / Terminated / root cause: software

FDA source

Biomeme, Inc. began a recall of The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplification technology. The... on 2020-10-23. FDA classified it as Class II and gives the reason as "The firm has become aware of nine reports by a single customer that the software made false positive calls. The investigation determined that the root cause is the higher than expected amber-to-red co-excitation in the...". 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-0513-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-23
Posted: 2020-12-01
Terminated: 2021-01-25
Recalling firm: Biomeme, Inc.
Product: The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplification technology. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test contains primers and probes and internal controls used in RT-PCR for the in vitro qualitative detection of SARS-CoV-2 RNA in upper respiratory specimens. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test utilizes Biomemes M1 Sample Prep Cartridge for RNA extraction, Biomemes SARS-CoV-2 Go-Strips assay, and Biomemes portable Franklin" Real-Time qPCR Thermocycler. Franklins companion mobile app, Biomeme Go, scans tests, runs PCR experiments online or offline, and is used to quickly interpret your test results while conveniently syncing data to the Biomeme Cloud. Biomeme: 1000013 (Android Smartphone w/ Biomeme Go Mobile App) and Biomeme: 1000012 (Rugged Android Smartphone w/ Biomeme Go Mobile App) are controller for Biomeme Franklin thermocycler.
Product code: QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Reason for recall: The firm has become aware of nine reports by a single customer that the software made false positive calls. The investigation determined that the root cause is the higher than expected amber-to-red co-excitation in the assay.
Root cause tag: software
FDA root cause: Software design
Action: On 10/23/2020, the firm pushed the protocol update and the customer who initiated the complaint was notified. All other customers were informed of the update via email on 10/27/2020. Customers were told that the firm had deployed a change to their data processing algorithm specific to the SARS-CoV-2 protocol, which comprised of increasing the value of the co-excitation filter. Instruction to Customers: If your phone is not connected to the internet via wifi or cellular network, please connect the phone and login to the Biomeme Go app. The update will sync automatically to the Biomeme Go app and requires no further action if the phone running the Biomeme Go app is connected to wifi or a cellular network. The Before Fix Revision is 2020-03-24. The After Fix Revision is 2020-10-23. The firm also emphasized the importance to manually reviewing all results in the app or on the Biomeme Cloud. Should your PCR curves look at all suspect, contact the firm at [email protected]. All positive samples should be rerun.
Quantity in commerce: 105
Distribution: Worldwide distribution - US Nationwide distribution including in the states of CA, IN, NY, OH, PA, and the countries of Canada, Singapore, Zimbabwe, and Dominican Republic.
Product codes and lots: Revision 2020-03-24

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0513-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0513-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-09	2020-12-01

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)