Bd Diagnostic recalls BD Viper LT software, version 3.00H

Recall date

December 14, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1866-2017

FDA classification

Class II

Brand / firm

Bd Diagnostic

Sold / distributed

2 US customers, 0 Ex-US regions, and 0 distributors 0.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BD Viper LT software, version 3.00H