ThermoFisher Scientific Microm STP 420D automated tissue processor.
FDA device recall Z-1320-2010 · posted 2010-04-12 · Terminated
Recall details
- Recalling firm
- Thermo Fisher Scientific
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- IEO
- Quantity affected
- 16
- Distribution
- Hawaii, Kentucky, Louisiana, Michigan, Missouri, Nebraska, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and West Virginia.
- Date initiated
- 2009-06-03
- Date posted
- 2010-04-12
- Date terminated
- 2011-06-29
- Location
- Kalamazoo, MI
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