ThermoFisher Scientific Microm STP 420D automated tissue processor.
FDA Recall Z-1320-2010 · Posted 2010-04-12
Recalling FirmThermo Fisher Scientific
Recall StatusTerminated
Product CodeIEO
Date Initiated2009-06-03
Date Terminated2011-06-29
Product Quantity16
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Hawaii, Kentucky, Louisiana, Michigan, Missouri, Nebraska, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and West Virginia.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.