Recall Z-1866-2017 ยท OOI Real Time Nucleic Acid Amplification System
Bd Diagnostic
BD Viper LT software, version 3.00H
| Date | Apr 4, 2017 (initiated Dec 14, 2015) |
| Status | Terminated |
| Reason | BD has confirmed reports that lower than expected RFU values were generated on customer BD Viper LT Systems after the installation of software version 3.00H. As RFU values decrease, results approach the assay cutoff threshold which has the potential to impact test results. |
| Root cause | Software design |
| Action | Recall action was initiated on December 14, 2015 when software version 3.00H was removed from the two customer instruments. The 2 affected US customers were contacted via email and were also mailed a letter via UPS overnight express. |
| Quantity | 2 |
| Distribution | 2 US customers, 0 Ex-US regions, and 0 distributors 0. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140447 | BD VIPER LT SYSTEM Becton, Dickinson and Company, May 20, 2014 |