Class 2 Device Recall ThermoFisher Scientific Microm STP 420D

• Date Initiated by Firm: June 03, 2009
• Date Posted: April 12, 2010
• Recall Status: Terminated on June 29, 2011
• Recall Number: Z-1320-2010
• Recall Event ID: 52175
• Product Classification: Processor, tissue, automated - Product Code IEO
• Product: ThermoFisher Scientific Microm STP 420D automated tissue processor.
• Code Information: All units.
• Recalling Firm/ Manufacturer: Thermo Fisher Scientific; 4481 Campus Dr; Kalamazoo MI 49008-2590
• Manufacturer 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: 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 in Commerce: 16
• Distribution: Hawaii, Kentucky, Louisiana, Michigan, Missouri, Nebraska, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and West Virginia.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.