PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automated standarized al...
FDA Recall #Z-0287-2013 — Class II — May 1, 2008
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.
Recalling Firm
Dako North America Inc. — Carpinteria, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
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.
Code Information
Catalog #: PT-Module
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated