Home / Recalls / Dako North America Inc. / Z-1093-2014

Z-1093-2014 Class II Terminated

Recalled by Dako North America Inc. — Carpinteria, CA

Recall Details

Product Type
Devices
Report Date
March 5, 2014
Initiation Date
January 21, 2014
Termination Date
June 4, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
49

Product Description

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 for Recall

Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed.

Distribution Pattern

Worldwide Distribution - USA Nationwide and in the country of Chile.

Code Information

Catalog/Model number: SK109, lot 20000910. Shelf Life: 10 months when stored at 2-8 ¿C. Expiration Date: 2014 June 30.

Other recalls by Dako North America Inc.

  • Z-2425-2018 Class II — PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels (February 2, 2018)
  • Z-2099-2016 Class II — Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro (June 10, 2016)
  • Z-0220-2016 Class II — EnVision FLEX/HRP visualization reagent found in the following kits: EnVision F (September 4, 2015)
  • Z-1548-2015 Class II — Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Da (April 1, 2015)
  • Z-1261-2015 Class II — Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostain (February 12, 2015)
  • Z-2708-2014 Class II — Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 (August 29, 2014)
  • Z-0287-2013 Class II — PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automat (May 1, 2008)