Events

Recall of Device Recall BD FACS Sample Prep Assistant III (BD SPA III)

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
    55748
  • Event Risk Class
    Class 2
  • Event Number
    Z-0316-2011
  • Event Initiated Date
    2010-02-19
  • Event Date Posted
    2010-11-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91715
  • 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
    Counter, differential cell - Product Code GKZ
  • Reason
    Due to inaccurate sample dispense, use of product may result in getting incorrect results on samples prepared using the device. having a piece of the lid partially or fully clogging the probe during piercing a hole in the lid of tube may cause inaccurate sample dispense, resulting in incorrect test results. the piece of the lid clogging the probe can be in the processed sample tube. it has the.
  • Action
    BD Biosciences sent an "Important Product Information" letter dated February 2010 and an "URGENT: Follow-Up to Letter Dated February 2010" letter dated July 2010 to customers identifying the affected device and actions to be taken: Customers were instructed to stop use of the SPA probes and to contact BD for replacement of the affected probes and assistance in the event of probe clogging. BD has arranged replacement of affected probes. BD's followup communication detailed the potenial hazards and reiterated remedial actions in the event of error messages from FACS flow cytometers. Customers with questions about the performance of theirr SPA instrument or the content of the letters may contact BD Customer Support at 1.877.232.8995, prompt 2.

Device

Device Recall BD FACS Sample Prep Assistant III (BD SPA III)
  • Model / Serial
    Model/Catalog No. 647205. Manufacturing Lot/Serial # X0039; Sample Probe Catalog Numbers: 333494, 333485, 339118, 647768, and 647769/Lot Nos. 92035 and 92036
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including OH, NC, AL,TX, FL, CA, NY, and MN and the country of Belgium.
  • Product Description
    BD FACS Sample Prep Assistant III; (BD SPA III), Manufactured by BD Biosciences, San Jose, CA. || The intended use for the BD FACS Sample Prep Assistant is to prepare human whole blood samples for flow cytometry analysis.
  • 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