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Bd Diagnostic recalls BD Viper LT software, version 3.00H
Recalled April 26, 2017 · FDA recall Z-1866-2017 · Bd Diagnostic
Hazard
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. · FDA Class II
Units
2
Sold at
2 US customers, 0 Ex-US regions, and 0 distributors 0.
Description
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.
Product
BD Viper LT software, version 3.00H
Manufacturer(s)
Bd Diagnostic
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →