Home / Recalls / Dako North America Inc. / Z-0287-2013

Z-0287-2013 Class II Terminated

Recalled by Dako North America Inc. — Carpinteria, CA

Recall Details

Product Type
Devices
Report Date
November 21, 2012
Initiation Date
May 1, 2008
Termination Date
November 13, 2012
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
136 units

Product Description

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.

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.

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.

Code Information

Catalog #: PT-Module

Other recalls by Dako North America Inc.

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  • Z-1548-2015 Class II — Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Da (April 1, 2015)
  • Z-1261-2015 Class II — Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostain (February 12, 2015)
  • Z-2708-2014 Class II — Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 (August 29, 2014)
  • Z-1093-2014 Class II — Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910 (January 21, 2014)