Device product
BD Viper LT software, version 3.00H
Z-1866-2017
Product summary
- Firm
- Bd Diagnostic
- Event
- Event 76895
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-1866-2017
Official wording
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.
Code information: Catalog Number 443157 443153 443155 443156 442947 443902 Version Number 3.00H 3.00H
Distribution pattern: 2 US customers, 0 Ex-US regions, and 0 distributors 0.
Derived failure modes
-
Unknown
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.