Reported Mar 5, 2014 · Terminated
Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910 Product Usage: For in vitro diagnostic…
Dako North America Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dako North America Inc. · 6392 Via Real · Carpinteria, CA · 93013-2921
Is this the product you have?
- Product NameHER2
- CISH pharmDx Kit Catalog/Model numberSK109
- lot 20000910 Product UsageFor 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
- Lot codes and dates
- Catalog/Model number
SK109lot 20000910
- Shelf Life10 months when stored at 2-8 ¿C
- Expiration Date2014 June 30
- Catalog/Model number
- Amount recalled
- 49
Where it was sold
- Nationwide
Why it was recalled
Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed.
This product could cause temporary or reversible health problems — stop using it.
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