Recall Z-1320-2010 ยท IEO Processor, Tissue, Automated
Thermo Fisher Scientific
ThermoFisher Scientific Microm STP 420D automated tissue processor.
| Date | Apr 12, 2010 (initiated Jun 3, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 16 |
| Distribution | Hawaii, Kentucky, Louisiana, Michigan, Missouri, Nebraska, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and West Virginia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.