Recall Z-0287-2013 ยท IDY Bath, Flotation, Tissue
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.
| Date | Nov 13, 2012 (initiated May 1, 2008) |
| Status | Terminated |
| 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) |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.