Recall Z-2099-2016 ยท NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
Dako North America Inc.
Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dualcolor 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 in formalin-fixed, paraffin-emb
| Date | Jun 10, 2016 |
| Status | Terminated |
| Reason | An incorrect HER2 probe concentration was used when producing the probe component (Vial 3) in this kit lot. This has resulted in the HER2 probe concentration being too low. |
| Root cause | Process control |
| Action | Dako sent a recall notification dated June 10, 2016 to all customers. The letter identified the affected product, problem, the investigation findings, the affected results, and the actions to be taken. Customers are instructed to complete and return the enclosed device recall form to Dako QA Vigilance by Dako.dkvigilance@agilent.com. Customers with questions regarding the notification, are instructed to contact their sales representative. |
| Quantity | 31 kits |
| Distribution | Worldwide Distribution - US Nationwide in the states of: PA, CA, AL, NC and countries of Austria, Bosnia and Herzegovina, Belgium, Bulgaria, Brazil, Canada, Switzerland, Germany, Spain, France, Greece, Italy, Macedonia, Qatar, Romania, Serbia, Sweden, and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.