Veridex Recalls Cell Search Circulating Tumor Kits Due to Artifacts
Veridex, LLC is recalling 1,560 Cell Search Circulating Tumor Kits due to the presence of artifacts and control failures.
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, and the source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Veridex, LLC is recalling 1,560 units of the Cell Search Circulating Tumor Kit. This medical device is intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood. The affected kits are distributed nationwide and include Part Number 7900001, specifically Kit Lot Number 0074B (Exp Date 2015-10-08) and Kit Lot Number 0094B (Exp Date 2015-12-12).
The recall was initiated due to complaints regarding the presence of artifacts that appear as small bead-like structures in the image gallery when processing both control cells and patient samples. Additionally, there were reports of the failure of high control cells.
Healthcare providers and laboratories should stop using the affected kits and contact Veridex, LLC for instructions on how to return or dispose of the product.
The recalled product
- Product
- Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.
- Manufacturer
- Veridex, LLC
- Affected units
- 1,560
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 (3)
- Part Number 7900001
- Kit Lot Number 0074B Exp Date 2015-10-08
- Kit Lot Number 0094B Exp Date 2015-12-12
Distribution
Distributed nationwide across the United States.
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