The Recall Desk
HighFDA (Devices)·Z-0287-2013·Announced 2012-11-21

Dako PT Link Waterbath Recalled for Electrical Shock Hazard

Dako North America Inc. is recalling 136 PT Link Waterbath units due to a potential electrical shock hazard if the heater pad becomes wet.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (electrical shock) where injury has not yet been reported, which aligns with the High severity criteria in the rubric.

Plain-English summary

Dako North America Inc. is recalling 136 units of the PT Link Waterbath, Model#PT100. The device, also known as the Lab Vision PT Module Plus, is used to provide an automated standardized alternative to labor-intensive dewaxing and epitope retrieval procedures.

The recall is being issued because of a possible electrical hazard. Specifically, if the heater pad located under the reagent tank becomes wet, it may present an electrical shock hazard when the lid is open.

The affected units were distributed nationwide in the United States, including the 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. The catalog number for the affected product is PT-Module.

The recalled product

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.
Affected units
136

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Catalog #: PT-Module

Distribution

Distributed nationwide across the United States.

The notice also names 31 states specifically: