Z-2099-2016 Class II Terminated
FDA device recall Z-2099-2016 was initiated by Dako North America Inc. on June 10, 2016 and is designated Class II. Reason for recall: An incorrect HER2 probe concentration was used when producing the probe component (Vial 3) in this kit lot. This has resulted in the HER2 probe concentration being too low. The recall status is terminated (terminated September 2, 2016). Affected quantity: 31 kits.
Recall Details
- Product Type
- Devices
- Report Date
- July 6, 2016
- Initiation Date
- June 10, 2016
- Termination Date
- September 2, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31 kits
Product Description
Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dualcolor 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
An incorrect HER2 probe concentration was used when producing the probe component (Vial 3) in this kit lot. This has resulted in the HER2 probe concentration being too low.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of: PA, CA, AL, NC and countries of Austria, Bosnia and Herzegovina, Belgium, Bulgaria, Brazil, Canada, Switzerland, Germany, Spain, France, Greece, Italy, Macedonia, Qatar, Romania, Serbia, Sweden, and Turkey.
Code Information
20031683