Dako HER2 CISH pharmDx Kit Recalled Due to Weak Red Signals
Dako North America Inc. is recalling 49 units of the HER2 CISH pharmDx Kit because weak red signals have been observed.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a performance defect (weak signals) that could lead to inaccurate diagnostic results, but no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Dako North America Inc. has initiated a recall of the HER2 CISH pharmDx Kit, catalog number SK109, lot 20000910. The recall affects 49 units of the product, which is intended for in vitro diagnostic use to determine HER2 gene status in breast cancer tissue specimens.
The recall was initiated because weak red signals have been observed in the product. The kit is designed to generate red and blue chromogenic signals for evaluation under bright field microscopy, and the observed weakness in the red signal may affect the accuracy of the diagnostic results.
The affected units were distributed nationwide in the United States and in Chile. The expiration date for the recalled lot is June 30, 2014. Users of the product should stop using the affected kits and contact Dako North America Inc. for further instructions.
The recalled product
- 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 target
- Manufacturer
- Dako North America Inc.
- Hazard
- Affected units
- 49
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog/Model number: SK109
Distribution
Distributed nationwide across the United States.
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