Reported Dec 9, 2020 · Terminated
The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used…
Biomeme, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biomeme, Inc. · 1015 Chestnut St · Philadelphia, PA · 19107-4316
Is this the product you have?
- 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
- Biomeme1000013 (Android Smartphone
- w/ Biomeme Go Mobile App) and Biomeme1000012 (Rugged Android Smartphone w/ Biomeme Go Mobile App) are controller for Biomeme Franklin thermocycler
- Lot codes and dates
- Revision 2020-03-24
- Amount recalled
- 105
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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