PT Link Waterbath — Class II medical device recall Z-0287-2013
Terminated recall by Dako North America Inc., reported 2012-11-21, distributed nationwide. Dako is recalling the PT Link Waterbath because of a possible electrical hazard. Specifically, if the heater p
| Recall number | Z-0287-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dako North America Inc., Carpinteria, CA, United States |
| Recall initiated | 2008-05-01 |
| Classified | 2012-11-13 |
| Reported by FDA | 2012-11-21 |
| Terminated | 2012-11-13 |
| Distributed | Nationwide (US) |
| Quantity | 136 units |
| Model numbers | PT100 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0287-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.