Events

Recall of VP 2000 Processor

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

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
    52055
  • Event Risk Class
    Class 3
  • Event Number
    Z-1929-2009
  • Event Initiated Date
    2008-09-15
  • Event Date Posted
    2009-08-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-01-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82005
  • 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
    Automated Tissue Stainer - Product Code KEY
  • Reason
    Thermal runaway conditions, in that the target temperature was exceeded and the temperature display could not track the actual temperature within the heated slide basins of the vp 2000 slide processor.
  • Action
    Abbott sent Device Recall/Urgent Field Safety Notice letters dated 9/15/08 to the VP2000 customers on 9/12/08, informing them that thermal runaway conditions may occur within the heated slide basins of the VP2000 Slide Processor. The customers were given actions to take to prevent this condition: a) VP2000 should be powered down when not in use and when the controlling computer is not in use; b) Liquid level in all heated basins should be checked periodically to ensure that there is adequate reagent present for slide processing and to keep the sensor probe immersed for accurate temperature sensing; and c) If large, rapid and random fluctuations in indicated basin temperature occurs the unit should be shut down and a Field Service Representative be contacted. Any questions were directed to their local Abbott Technical Service Representative.

Device

VP 2000 Processor
  • Model / Serial
    all units
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Columbia, Czech Republic, Egypt, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Korea, Malaysia, Norway, Russia, Saudi Arabia, Singapore, Switzerland and the United Kingdom.
  • Product Description
    VP 2000 Processor; an automated tissue stainer || 100 volt - part 30-144100 or list 2J11-60; || 117 volt - part 30-144101 or list 2J11-01, and part 30-102832 - processor only; || 230 volt - part 30-144102 or list 2J11-04, and part 30-102833 processor only. || Designed to automate and standardize slide specimen processing including deparafinization, FISH pretreatment and routine slide staining for the laboratory. The unit is preprogrammed to perform slide pretreatment protocols for FISH assays and can be programmed to perform routine histology/cytology slide staining or routine slide washing according to user requirements.
  • Manufacturer
    Abbott Molecular

Manufacturer

Abbott Molecular
  • Manufacturer Address
    Abbott Molecular, 1300 E Touhy Ave, Des Plaines IL 60018-3315
  • Source
    USFDA