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Dako North America Inc. recalls Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910 Product Usage: For in vitro diagnosti
Recalled March 5, 2014 · FDA recall Z-1093-2014 · Dako North America
Hazard
Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed. · FDA Class II
Units
49
Sold at
Worldwide Distribution - USA Nationwide and in the country of Chile.
Description
Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed.
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.
Manufacturer(s)
Dako North America Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →