Recall Z-1195-2014 ยท NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Veridex, LLC
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). The system also supports an optional Remote Review Workstation (RRW), which consists of a dedicated computer with CELLTRACKS sof
| Date | Mar 13, 2014 (initiated Jan 8, 2014) |
| Status | Terminated |
| Reason | Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II. |
| Root cause | Device Design |
| Action | Janssen Diagnostics, LLC sent an Important Product Correction Notification letter dated January 8, 2014 to all affected customers via FedEx overnight courier letter and Foreign Affiliate Consignees by email on January 8, 2014. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the Confirmation of Receipt Response form attached. For questions contact Customer Technical Service at 1-877-837-4339. |
| Quantity | 19 units |
| Distribution | Worldwide Distribution - USA Nationwide |
| FDA record | Open on fda.gov |