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U.S. Department of Health and Human Services

Enforcement Report - Week of November 21, 2012

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Event Detail

Event ID 53336
Product Type Devices
Status Terminated
Recalling Firm Dako North America Inc.
City Carpinteria
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2008-05-01
Initial Firm Notification of
Consignee or Public
Distribution Pattern 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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Catalog #: PT-Module Class II 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. 136 units Z-0287-2013