Reported Mar 19, 2014 · Terminated
CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence…
Veridex, LLC
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: Veridex, LLC · 1001 US Route 202 · Raritan, NJ · 08869-0606
Is this the product you have?
- CELLTRACKS ANALYZER II¿ (Product
- Code 9555) Product UsageThe 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). The system also supports an optional Remote Review Workstation (RRW), which consists of a dedicated computer with CELLTRACKS¿ software, monitor, keyboard and mouse. Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II¿ is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS¿ AUTOPREP¿ System, which automates and standardizes the sample preparation with specific reagent kits. An optional Remote Review Workstation is also available to provide the capability to review images and report results remotely
- Lot codes and dates
- FirstK050145
- cleared 15 March 2005 Latest
K130794cleared 20
- June 2013 9555 Serial numbers
CT1106005CT1104002CT1108006CT1111009CT1201001CT1203004CT1205011CT1205012CT1206013CT1210022CT1210024
- Amount recalled
- 19 units
Where it was sold
- Nationwide
Why it was recalled
Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II¿.
This product could cause temporary or reversible health problems — stop using it.
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