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
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Dako North America Inc.
Lot Codes / Batch Numbers
Catalog #: PT-Module
Products Sold
Catalog #: PT-Module
Dako North America Inc. is recalling PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automated standarized alter due to Dako is recalling the PT Link Waterbath because of a possible electrical hazard. Specifically, if the heater pad under the reagent tank becomes wet,. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 11, 2026