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U.S. Department of Health and Human Services

Class 2 Device Recall PT100/PT Link Waterbath

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 Class 2 Recall
PT100/PT Link Waterbath
see related information
Date Posted November 13, 2012
Recall Status1 Terminated on November 13, 2012
Recall Number Z-0287-2013
Recall Event ID 53336
Product Classification Bath, Flotation, Tissue - Product Code IDY
Product PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automated standarized alternative to labor intensive and time consuming dewaxing and epitote retrieval procedures.
Code Information Catalog #: PT-Module
Recalling Firm/
Manufacturer
Dako North America Inc.
6392 Via Real
Carpinteria, California 93013-2921
Manufacturer Reason
for Recall
Dako is recalling the PT Link Waterbath because of a possible electrical hazard. Specifically, if the heater pad under the reagent tank becomes wet, it may present an electrical shock hazard when the lid is open.
FDA Determined
Cause 2
DESIGN: Device Design
Action The firm, Dako, sent a "DAKO PT LINK ADVISORY NOTICE" dated May 1, 2008 to customers who purchased the PT Waterbath along with a customer acknowledgement document informing the users of the potential electrical hazard. The notice described the product, problem and actions to be taken. The customers were instructed to follow the attached Safety Instructions; place the enclosed warning labels directly on the instrument as shown in the attached instructions and adhere to the warning labels as described. Customers with questions were instructed to call Dako Products' Technical Support at (800) 424-0021.
Quantity in Commerce 136 units
Distribution Nationwide distribution: USA including states of: AK, CA, CO, CT, DC, FL, GA, HI, IA, IL IN, KS, KY, MA, MD, MI, MN, MO, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, and WA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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