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U.S. Department of Health and Human Services

Class 3 Device Recall VP 2000 Processor

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  Class 3 Device Recall VP 2000 Processor see related information
Date Initiated by Firm September 15, 2008
Date Posted August 30, 2009
Recall Status1 Terminated 3 on January 07, 2010
Recall Number Z-1929-2009
Recall Event ID 52055
Product Classification Automated Tissue Stainer - Product Code KEY
Product 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.
Code Information all units
Recalling Firm/
Abbott Molecular
1300 E Touhy Ave
Des Plaines IL 60018-3315
For Additional Information Contact Dr. Kenneth Emancipator
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Device Design
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.
Quantity in Commerce 261 units
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.