VP 2000 Processor; an automated tissue stainer 100 volt - part 30-144100 or list 2J11-60; 117 volt - part 30-144101 or l

FDA device recall Z-1929-2009 · posted 2009-08-30 · Terminated

Recall details

Recalling firm

Abbott Molecular

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

KEY

Quantity affected

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 Ar

Date initiated

2008-09-15

Date posted

2009-08-30

Date terminated

2010-01-07

Location

Des Plaines, IL