FDA-Device2017-04-26Class II
BD Viper LT software, version 3.00H
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.
Sold states
2 US customers, 0 Ex-US regions, and 0 distributors 0.
Affected count
2
Manufactured in
54 Loveton Circle Mc 912, N/A, Sparks, MD, United States
Products
BD Viper LT software, version 3.00H
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1866-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief