Events

Recall of Device Recall SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Separation Technology, 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
    64718
  • Event Risk Class
    Class 2
  • Event Number
    Z-1367-2013
  • Event Initiated Date
    2013-03-13
  • Event Date Posted
    2013-05-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117450
  • 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
    Cytocentrifuge - Product Code IFB
  • Reason
    Separation technology, inc. recalled slideprep plus cytology centrifuges manufactured prior to january 1, 2013 for having the potential to start up unexpectedly when encountering an electrostatic discharge.
  • Action
    On March 13, 2013, Separation Technology, Inc. sent their customers letters instructing them to complete and return the attached Acknowledgement & Receipt form via fax to (407) 788-3677 and requesting the return of the SlidePrep Plus Cytology Centrifuges to STI for correction. For any questions regarding this recall, call STI Customer Service at (800) 777-6668.

Device

Device Recall SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE
  • Model / Serial
    Serial numbers: 0110, 0111, 0112, 0210, 0211, 0212, 0310, 0311, 0312, 0410, 0411, 0412, 0511, 0512, 0611, 0710, 0711, 0811, 0812, 0910, 0911, 0912, 1011, 1012, 1112, 1210, 1212.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of PA, NC, IL, KS, and FL, and the countries Canada and Turkey.
  • Product Description
    SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE. || Produce a monolayer of cells onto a glass slide from any fluid suspension.
  • Manufacturer
    Separation Technology, Inc.

Manufacturer

Separation Technology, Inc.
  • Manufacturer Address
    Separation Technology, Inc., 582 Monroe Rd Ste 1424, Sanford FL 32771-8821
  • Source
    USFDA