Device 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.
Z-1093-2014
Product summary
- Event
- Event 67380
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49
- Official record key
device-enforcement:Z-1093-2014
Official wording
Reason: Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed.
Code information: Catalog/Model number: SK109, lot 20000910. Shelf Life: 10 months when stored at 2-8 ¿C. Expiration Date: 2014 June 30.
Distribution pattern: Worldwide Distribution - USA Nationwide and in the country of Chile.
Derived failure modes
-
Unknown
Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed.