Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109 — Class II medical device recall Z-1093-2014
Terminated recall by Dako North America Inc., reported 2014-03-05, distributed nationwide. Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed.
| Recall number | Z-1093-2014 |
|---|---|
| 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 | 2014-01-21 |
| Classified | 2014-02-25 |
| Reported by FDA | 2014-03-05 |
| Terminated | 2014-06-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | CL |
| Quantity | 49 |
| Lot numbers | 20000910 |
| Model numbers | SK109 |
Product
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 in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The CISH procedure is automated using Dako Autostainer instruments. HER2 CISH pharmDx Kit is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered. Results from the HER2 CISH pharmDx Kit are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients.
Reason for recall
Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed.
Machine access
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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.