Bd Diagnostic: Medical Device Recall in 2017 - (Recall #: Z-1866-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

BD Viper LT software, version 3.00H

Product Classification:

Class II

Date Initiated: December 14, 2015

Date Posted: April 26, 2017

Recall Number: Z-1866-2017

Event ID: 76895

Reason for Recall:

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.

Status: Terminated

Product Quantity: 2

Code Information:

Catalog Number 443157 443153 443155 443156 442947 443902 Version Number 3.00H 3.00H

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated