Recall Z-0287-2013— Dako North America Inc.
Class II · Terminated
Class II FDA medical device recall by Dako North America Inc., initiated 2008-05-01, terminated 2012-11-13. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Dako North America Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2008-05-01
- Terminated
- 2012-11-13
- Firm location
- Carpinteria, CA, United States
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.