Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in Recalled by Biomeme, Inc. Due to The firm has become aware of nine reports...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Biomeme, Inc. directly.
Affected Products
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.
Quantity: 105
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Biomeme, Inc.
Biomeme, Inc. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report