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Recall Observatory FDA recall evidence

Device 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.

Z-0287-2013

May 01, 2008

Class II

Product summary

Firm
Dako North America Inc.
Event
Event 53336
Status
Terminated
Classification
Class II
Quantity
136 units
Official record key
device-enforcement:Z-0287-2013

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.