Recall Z-1929-2009 ยท KEY Stainer, Tissue, Automated
Abbott Molecular
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 laborat
| Date | Aug 30, 2009 (initiated Sep 15, 2008) |
| Status | Terminated |
| 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. |
| Root cause | 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 s |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.