Recall Z-0513-2021 ยท QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Biomeme, Inc.
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 uti
| Date | Oct 23, 2020 |
| Status | Terminated |
| Reason | 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 | 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 a |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.