Events

Recall of Device Recall PrepStain GN 480 Disposable Kit

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

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
    61737
  • Event Risk Class
    Class 3
  • Event Number
    Z-1815-2012
  • Event Initiated Date
    2012-03-22
  • Event Date Posted
    2012-06-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108863
  • 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
    Processor, cervical cytology slide, automated - Product Code MKQ
  • Reason
    The prepstain syringing pipettes may not dispense the minimum volume of 7.5 ml of the sample due to leaking. this event resulted in an increase in complaints of leaking syringing pipettes.
  • Action
    BD Diagnostics sent a "BD PrepMate Syringing Pipette" letter dated March 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The firm encouraged customers to refer to the Operator's Manual and inspect the centrifuge tubes to verify that the correct amount of sample has been transferred. Customers experiencing this issue were instructed to discard the pipettes and contact BD Diagnostic Technical Support for a replacement. Contact the firm at 1-877-822-7771 for questions regarding this notice.

Device

Device Recall PrepStain GN 480 Disposable Kit
  • Model / Serial
    This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the actual product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240), which are: 100901a, 100902f, 100902f, 100903d, 100908c, 100910c, 100914f, 100916d, 100921d, 100928c, 101005a, 101007d, 101008c, 101012c, 101013a, 101015c, 101020d, 101022c, 101027a, 101028c, 101029d, 101103b, 101105h, 101110f, 101111c, 101117p, 101118n,  101119c, 101130p, 101201o, 101207o, 101208p, 101210c, 101213n, 101214b, 101214c,  101217b, 101220q, 101221g, 110104b, 110106a, 110107c, 110110d, 110112n, 110118b,  110128i, 110203i, 110210r
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    PrepStain GN 480 Disposable Kit Catalog/Model 490542 || This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240)
  • Manufacturer
    Tripath Imaging, Inc.

Manufacturer

Tripath Imaging, Inc.
  • Manufacturer Address
    Tripath Imaging, Inc., 780 Plantation Dr, Burlington NC 27215-6723
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA