Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

BD Viper LT software Recalled by Bd Diagnostic Due to BD has confirmed reports that lower than expected...

Date: December 14, 2015
Company: Bd Diagnostic
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Bd Diagnostic directly.

Affected Products

BD Viper LT software, version 3.00H

Quantity: 2

Why Was This 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.

Where Was This Sold?

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

About Bd Diagnostic

Bd Diagnostic has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report