FDADecember 14, 2015device
BD Viper LT software, version 3.00H
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
bd diagnostic
Recall history
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