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.
FDA Recall Z-1093-2014 · Posted 2014-02-26
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Recalling FirmDako North America Inc.
Recall StatusTerminated
Product CodeNYQ
Date Initiated2014-01-21
Date Terminated2014-06-04
Product Quantity49
Reason for Recall
Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed.
Firm Action
Dako sent a Recall Notification letter dated January 21, 2014to affected customers via mail. The letter identified the affected product, description of the problem, actions to be taken by the user, communication, and Dako contact information. The letter was accompanied by a "Recall Form (Product Recall Form to customers)". For questions call 805-566-5464.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - USA Nationwide and in the country of Chile.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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