FDA Medical Device Recalls (openFDA)
Dako North America Inc.: 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.
- Recall number
- Z-0287-2013
- Recalling firm
- Dako North America 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.
- Status
- Terminated
- Initiated
- 2008-05-01
- Posted
- 2012-11-13
- Terminated
- 2012-11-13
- 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.
- 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
- 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.
- Lot, serial or model codes
- Catalog #: PT-Module
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IDY
- Firm FEI
- 2022180
- Firm city
- Carpinteria
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28