Z-1093-2014Class II

Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910

Name: Z-1093-2014 Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910
Creator: Dako North America Inc.
Published: 2014-01-21
License: https://open.fda.gov/license/

Agilent Technologies, Inc. / initiated 2014-01-21 / Terminated / root cause: design

FDA source

Dako North America Inc. began a recall of 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... on 2014-01-21. FDA classified it as Class II and gives the reason as "Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1093-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-21
Posted: 2014-02-26
Terminated: 2014-06-04
Recalling firm: Agilent Technologies, Inc.
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.
Product code: NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
Reason for recall: Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 49
Distribution: Worldwide Distribution - USA Nationwide and in the country of Chile.
Product codes and lots: Catalog/Model number: SK109, lot 20000910. Shelf Life: 10 months when stored at 2-8 ¿C. Expiration Date: 2014 June 30.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1093-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1093-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-25

Product code NYQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)