Recall Z-1093-2014— Dako North America Inc.

Class II FDA medical device recall by Dako North America Inc., initiated 2014-01-21, terminated 2014-06-04. FDA's recall record names no specific 510(k) clearance for this event. 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: Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed..

Recalling firm

Dako North America Inc.

Classification

Class II

Status

Terminated

Initiated

2014-01-21

Terminated

2014-06-04

Firm location

Carpinteria, CA, United States

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