Events

Recall of Device Recall BD FACS Sample Prep Assistant II (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
    55654
  • Event Risk Class
    Class 2
  • Event Number
    Z-1940-2010
  • Event Initiated Date
    2010-02-19
  • Event Date Posted
    2010-06-30
  • 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=91636
  • 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
    blood sample preparer for flow cytometry analysis - Product Code GKZ
  • Reason
    Samples prepared on the bd spa ii, sn t0076 produced inaccurate sample results due to inaccurate sample dispensed as a result of the cap piercing probe.
  • Action
    The firm filed an MDR and implemented a field action consisting of a February 2010 notification letter and product replacement of affected probes. A CAPA for the probe design has been implemented. Effectivity is being tracked via mail and follow up phone call.

Device

Device Recall BD FACS Sample Prep Assistant II (SPA II)
  • Model / Serial
    Sample Probe Catalog Numbers 337170, 333494, 333485, 339118, 647768, 647769, and lot numbers , 92035 and 92036.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, Australia, Belgium, China (Hong Kong), Colombia, Jamaica, Korea, Mexico, Singapore and Uruguay.
  • Product Description
    BD Biosciences, BD FACS Sample Prep Assistant II (SPA II), blood sample preparer 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