Events

Recall of Device Recall BD MAX System

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

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
    76900
  • Event Risk Class
    Class 2
  • Event Number
    Z-1864-2017
  • Event Initiated Date
    2015-07-29
  • 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=154530
  • 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
    Software, transmission and storage, patient data - Product Code NSX
  • Reason
    The bd max system software version 4.44a contains a software anomaly that has the potential to affect some open system reagent (osr) customers utilizing user defined protocol (udp) assays. customers utilizing only ivd assays are not affected. this anomaly may cause the osr customer system to incorrectly switch the columns of the truth table on the users display. if the user tries to fix their display data, the display will appear correct however, the database may become incorrect, potentially resulting in incorrect results reporting. bd is able to trace the issue to a limited number of instruments that have software version 4.44a installed. note that the problem only affects customers that are either creating a new udp with result logic or modifying the result logic of an existing udp.
  • Action
    BD sent an Urgent Field Corrective Action Recall notification was initiated on July 29, 2015. The customer was initially contacted via a phone call and subsequently provided with a written communication. All US customers were contacted directly by phone and provided the written communication. Global holds were placed on July 21, 2015 and July 24, 2015. For further questions, please call (410) 316-4000.

Device

Device Recall BD MAX System
  • Model / Serial
    Catalog number 441916
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of : CA, CO, FL, IL, MN, MO, MT, NE, NJ, NY, OH, OR, PA, TX, TN, WA, WI., and to the countries of : Canada, Hong Kong, Taiwan, Turkey and Europe. Federal Government Agency sales/distribution centers or foreign countries VA Fort Harrison and VAMC Austin.
  • Product Description
    Software version 4.44A utilized on the BD MAX System
  • Manufacturer
    BD LIFE SCIENCES

Manufacturer

BD LIFE SCIENCES
  • Manufacturer Address
    BD LIFE SCIENCES, 54 Loveton Cir, Sparks Glencoe MD 21152-9202
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA