Dako HER2 CISH pharmDx Kit Recalled for Incorrect Probe Concentration
Dako North America Inc. is recalling 31 kits of the HER2 CISH pharmDx Kit because the HER2 probe concentration was too low.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The defect is a manufacturing error resulting in low probe concentration, which is a quality issue rather than a direct physical hazard like a structural defect or contamination.
Plain-English summary
Dako North America Inc. is recalling 31 kits of the Dako HER2 CISH pharmDx Kit, product code SK 109. The recall is due to an incorrect HER2 probe concentration used during the production of the probe component (Vial 3) in this specific lot.
The error resulted in the HER2 probe concentration being too low. The kit is intended for in vitro diagnostic use to determine HER2 gene status in breast cancer tissue specimens. The affected lot, code 20031683, was distributed worldwide, including in the United States (PA, CA, AL, NC) and various international locations.
Healthcare facilities and laboratories should stop using the affected kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- 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 centromer
- Manufacturer
- Dako North America Inc.
- Affected units
- 31
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)
- 20031683
Distribution
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