Recall Z-1320-2010
Thermo Fisher Scientific · initiated June 3, 2009
Product
ThermoFisher Scientific Microm STP 420D automated tissue processor.
Codes / lots: All units.
Reason for recall
The firm has received complaints regarding specimen integrity (higher rate of specimen fragmentation) as well as complaints that the chamber may stop rotating prematurely, resulting in sample deterioration.
FDA-determined cause: Other
Action taken
Consignees were notified of the problem by letter, on or about 6/3/09, updating the instructions for use. The units were subsequently upgraded on or before 9/8/09. For additional questions and information, please contact ThermoFisher's Technical Support department , Subject: PT Module Advisory Notice.
Details
- Recall number
- Z-1320-2010
- Initiated
- June 3, 2009
- Posted by FDA
- April 12, 2010
- Terminated
- June 29, 2011
- Product code
- IEO – Processor, Tissue, Automated
- Quantity
- 16
- Distribution
- Hawaii, Kentucky, Louisiana, Michigan, Missouri, Nebraska, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and West Virginia.
- Recalling firm
- Thermo Fisher Scientific, Kalamazoo, MI