Events

Recall of BD PrepStain System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bd Diagnostic Systems Tripath.

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
    49548
  • Event Risk Class
    Class 2
  • Event Number
    Z-1090-2009
  • Event Date Posted
    2009-03-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73784
  • 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
    Cervical Cytology Slide Processor - Product Code MKQ
  • Reason
    Software error in the non-gyn program of some devices may cause non-gyn samples to be incorrectly transferred from centrifuge tubes to slides potentially result in mismatched patient results.
  • Action
    BD Diagnostics began contacting known non-gyn customers by phone on 09/26/2008. Customers were notified by Urgent - Important Product Information letter on 09/29/2008. They were advised to stop using the system until they complete a list of actions provided in the letter. A telephone contact number for Technical Support was provided in the letter. A permanent software based solution will be provided to customers when completed. They anticipate the software will be available in October 2008.

Device

BD PrepStain System
  • Model / Serial
    GYN software version 1.2, Non-GYN version 2.80; GYN software version 1.3.0.1, Non-GYN software version 2.80.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    BD PrepStain System, Model Number: 799-14000-00; Catalog Number: 05CR000021, 05CR00021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 799-14000-00R; Catalog Number: 05CR000021, 05CR000021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 7914000-00R. || PrepStain is a liquid-based thin layer cell preparation device for preparation and staining of Prep smear slides from cervical specimens in a liquid based format (gyn use) and of cytology examination slides from non-cervical specimens such as urine and lung lavage.
  • Manufacturer
    Bd Diagnostic Systems Tripath

Manufacturer

Bd Diagnostic Systems Tripath
  • Manufacturer Address
    Bd Diagnostic Systems Tripath, 4025 Stirrup Creek Dr, Durham NC 27703-9398
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA