Z-0287-2013Class II

PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automated standarized alternative to...

Name: Z-0287-2013 PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automated standarized alternative to...
Creator: Dako North America Inc.
Published: 2008-05-01
License: https://open.fda.gov/license/

Agilent Technologies, Inc. / initiated 2008-05-01 / Terminated / root cause: design

FDA source

Dako North America Inc. began a recall of PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automated standarized alternative to labor intensive and time consuming dewaxing and... on 2008-05-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0287-2013
Classification: Class II
Status: Terminated
Initiated: 2008-05-01
Posted: 2012-11-13
Terminated: 2012-11-13
Recalling firm: Agilent Technologies, Inc.
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.
Product code: IDY Bath, Flotation, Tissue
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.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Dako, sent a "DAKO PT LINK ADVISORY NOTICE" dated May 1, 2008 to customers who purchased the PT Waterbath along with a customer acknowledgement document informing the users of the potential electrical hazard. The notice described the product, problem and actions to be taken. The customers were instructed to follow the attached Safety Instructions; place the enclosed warning labels directly on the instrument as shown in the attached instructions and adhere to the warning labels as described. Customers with questions were instructed to call Dako Products' Technical Support at (800) 424-0021.
Quantity in commerce: 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.
Product codes and lots: Catalog #: PT-Module

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0287-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0287-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-21	2012-11-13

Product code IDY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)