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U.S. Department of Health and Human Services

Class 2 Device Recall Cryostat Microtome, Thermo Scientific Microm HM 550 Cold Disinfection Cryostat

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  Class 2 Device Recall Cryostat Microtome, Thermo Scientific Microm HM 550 Cold Disinfection Cryostat see related information
Date Initiated by Firm September 23, 2010
Date Posted March 21, 2011
Recall Status1 Terminated 3 on April 02, 2012
Recall Number Z-1735-2011
Recall Event ID 57232
Product Classification Microtome, cryostat - Product Code IDP
Product Thermo Scientific HM 560 Cold Disinfection Cryostat, Microm International GmbH, Waldorf, Germany
Tissue processing equipment used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.
Code Information Upgrade 37379, Upgrade 40963, Upgrade 41256, 47686, 47778, 47927, 47981, 48018, 48019, 48052, 48053, 48125, 48126, 48127, 48352, 48559, 46594, 47048, 47064, 47213, 47226, 47737, 47738, 47874, 47875, 48228, 48229, 48355, 48356, 46607, 46608, 48350, 46605, 47693, 48629, 48022, 48227, 48134, 46823, 46824, 48716, 43642.
Recalling Firm/
Manufacturer		 Thermo Fisher Scientific
4481 Campus Dr
Kalamazoo MI 49008-2590
Manufacturer Reason
for Recall		 Through internal quality review, firm determined the need to conduct a more comprehensive system validation to support the claim of complete bacterial, fungal and viral disinfection efficacy.
FDA Determined
Cause 2		 Device Design
Action ThermoFisher sent Advisory Notice letters beginning on September 28, 2010, to all affected customers. The letters stated that the firm needed to conduct more comprehensive system validation data on the Cold-Disinfection sytem option available on the HM550-D cryostat to support the claim of complete bacterial, fungal and viral disinfection efficacy. The letter recommended that the Cold Disinfection option on the HM550-D not be used as the sole disinfection method on the HM550-D until the validation work is completed. The firm provided addtional safety protocols pertaining to the cryostat disinfection. Customers were instructed to complete and fax the Confirmation of Receipt Form to Technical Support, COLD-D Advisory Notice at (269) 372-2436.
Quantity in Commerce 100 units
Distribution Worldwide Distribution - USA including the states of LA, OH, FL, MD, PA, TX, MO, WI, KS, AL, CA, VA, MS, IL, NE, MA, and the countries of Australia, Belgium, China, Czech Republic, Denmark, Estonia, Finnland, France, Germany, Hong Kong, India, Italy, Japan, Netherlands, Norway, Poland, Portugal, Russia, Spain, Sweden, Taiwan, and the UK.
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.
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