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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 Device Recall PT100/PT Link Waterbath see related information
Date Initiated by Firm May 01, 2008
Date Posted November 13, 2012
Recall Status1 Terminated 3 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 CA 93013-2921
For Additional Information Contact
800-235-5743
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		 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 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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