Recall Z-1093-2014 ยท NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
Dako North America Inc.
Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dual-color chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome 17. The kit is designed to quantitatively determine HER2 gene status
| Date | Feb 26, 2014 (initiated Jan 21, 2014) |
| Status | Terminated |
| Reason | Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed. |
| Root cause | Device Design |
| Action | Dako sent a Recall Notification letter dated January 21, 2014to affected customers via mail. The letter identified the affected product, description of the problem, actions to be taken by the user, communication, and Dako contact information. The letter was accompanied by a "Recall Form (Product Recall Form to customers)". For questions call 805-566-5464. |
| Quantity | 49 |
| Distribution | Worldwide Distribution - USA Nationwide and in the country of Chile. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.