Events

Recall of Device Recall BD FACS Sample Prep Assistant II

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

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
    45880
  • Event Risk Class
    Class 2
  • Event Number
    Z-0526-2008
  • Event Initiated Date
    2007-10-02
  • Event Date Posted
    2008-04-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66398
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    Differential Cell Counter - Product Code GKI
  • Reason
    Mixing performance: spa ii devices manufactured with the affected product motor control board may exhibit suboptimal mixing performance.
  • Action
    On 10/1/07, all consignees were notified via Important Product Information letter and also an on-site visit by the firm's sales representative. The letter informed users of the affected product and provided instructions on the recall. For additional concerns or questions contact BD Customer Support Center at 1-877-232-8995.

Device

Device Recall BD FACS Sample Prep Assistant II
  • Model / Serial
    Serial Numbers: T0246 to T0290 (except for T0274,T0275,T0277 and T0279)
  • Product Classification
    Hematology and Pathology Devices
  • Distribution
    Worldwide Distribution --- USA including states of: NJ, IL, TX, PA, NY, MN, and AZ, and countries of Australia, Belgium, Hong Kong, Trinidad and Tobago. Australia, Belgium, Hong Kong, Trinidad and Tobago.
  • Product Description
    BD FACS Sample Prep Assistant II, Part Number: 337170; || Product is manufactured and distributed by BD Biosciences, San Jose, CA 95131
  • Manufacturer
    BD Biosciences

Manufacturer

BD Biosciences