Events

Recall of Device Recall BD Viper LT software, version 3.00H

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bd Diagnostic.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76895
  • Event Risk Class
    Class 2
  • Event Number
    Z-1866-2017
  • Event Initiated Date
    2015-12-14
  • Event Date Posted
    2017-04-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154526
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    real time Nucleic acid amplification system - Product Code OOI
  • Reason
    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.
  • Action
    Recall action was initiated on December 14, 2015 when software version 3.00H was removed from the two customer instruments. The 2 affected US customers were contacted via email and were also mailed a letter via UPS overnight express.

Device

Device Recall BD Viper LT software, version 3.00H
  • Model / Serial
    Catalog Number   443157 443153 443155 443156 442947 443902  Version Number    3.00H  3.00H
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    2 US customers, 0 Ex-US regions, and 0 distributors 0.
  • Product Description
    BD Viper LT software, version 3.00H
  • Manufacturer
    Bd Diagnostic

Manufacturer

Bd Diagnostic
  • Manufacturer Address
    Bd Diagnostic, 54 Loveton Circle Mc 912, Sparks MD 21152
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA