Class 2 Device Recall Biomeme SARSCoV2 RealTime RTPCR Test

• Date Initiated by Firm: October 23, 2020
• Create Date: December 01, 2020
• Recall Status: Terminated on January 25, 2021
• Recall Number: Z-0513-2021
• Recall Event ID: 86757
• Product Classification: Reagents, 2019-novel coronavirus nucleic acid - Product Code QJR
• 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.
• Code Information: Revision 2020-03-24
• Recalling Firm/ Manufacturer: Biomeme, Inc.; 1015 Chestnut St; Philadelphia PA 19107-4316
• Manufacturer 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.
• FDA Determined 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 support@biomeme.com. 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.