Veridex Recalls CELLTRACKS Analyzer II Microscopes Due to Camera Failures
Veridex, LLC is recalling 19 CELLTRACKS Analyzer II fluorescence microscopes because of reported camera failures. The devices are used for analyzing rare cells in biological fluids.
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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Veridex, LLC is recalling 19 units of the CELLTRACKS Analyzer II (Product Code 9555). This semi-automated fluorescence microscope system is used in laboratories to analyze rare cells isolated from biological fluids, such as whole blood. The recall is being conducted because Janssen Diagnostics, LLC received complaints regarding camera failures on the devices.
The affected units were distributed nationwide in the United States and worldwide. The recall includes specific serial numbers ranging from CT1106005 to CT1210024. The devices were cleared by the FDA between March 2005 and June 2013.
Healthcare facilities and laboratories using these devices should stop using the affected units and contact Veridex, LLC for instructions on how to proceed. The recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible health consequences.
The recalled product
- Product
- CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS¿ software, monitor, keyboard, mouse and uninterruptible power supply (UPS). T
- Manufacturer
- Veridex, LLC
- Hazard
- Affected units
- 19
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 (2)
- First: K050145
- cleared 15 March 2005 Latest: K130794
Distribution
Distributed nationwide across the United States.
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