Events

Recall of Device Recall BD FACS Sample Prep Assistant (SPA and SPA II)

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

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
    51208
  • Event Risk Class
    Class 2
  • Event Number
    Z-1620-2011
  • Event Initiated Date
    2009-01-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79200
  • 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
    Station, pipetting and diluting, for clinical use - Product Code JQW
  • Reason
    To prevent a needle stick while replacing the probe, the firm has initiated a field correction, and issued an improved users guide procedure (user bulletin, part number 645050).
  • Action
    The firm, BD Biosciences, sent an information letter dated December 2008 with an enclosed New Probe Replacement Service/User Bulletin, to the customers. The letter described the product, problem and action to be taken. The customers were instructed to review the attached User Bulletin (Part Number 645050); ensure that their laboratory follows the updated procedure for removing and replacing probe; place the User Bulletin in their BD FACS SPA or SPA II User's Guide; always follow the instructions in User Bulletin to properly remove and replace probe, and complete and return the Effectivity Form via fax to 408-577-1409. Should you have any comments or questions, please contact BD Biosciences at 1-877-232-8995 in the US. Outside the US, contact your regional BD office or field service engineer for assistance.

Device

Device Recall BD FACS Sample Prep Assistant (SPA and SPA II)
  • Model / Serial
    Lot Number: T0040
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and countries including: Hong Kong, Australia, Belgium, Canada, El Salvador, Hong Kong, Japan, and Mexico.
  • Product Description
    BD FACS Sample Prep Assistant (SPA and SPA II) Instrument, || Model Number: 334080, || Product is manufactured and distributed by BD Biosciences, San Jose, CA || The intended use for the BD FACS Sample Prep Assistant (SPA and SPA II) is to prepare human whole blood for flow cytometry.
  • Manufacturer
    BD Biosciences, Systems & Reagents

Manufacturer

BD Biosciences, Systems & Reagents
  • Manufacturer Address
    BD Biosciences, Systems & Reagents, 2350 Qume Dr, San Jose CA 95131-1812
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA