Dako North America Inc.: Medical Device Recall in 2012 - (Recall #: Z-0287-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 1, 2008

Date Posted: November 21, 2012

Recall Number: Z-0287-2013

Event ID: 53336

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.

Status: Terminated

Product Quantity: 136 units

Code Information:

Catalog #: PT-Module

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.

Voluntary or Mandated:

Voluntary: Firm initiated