Recall Z-0819-2010 ยท NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Veridex, LLC
CellSearch Circulating Tumor Cell Kit (Epithelial) IVD REF 7900001 Veridex LLC, a Johnson & Johnson Company.
| Date | Feb 23, 2010 (initiated Aug 12, 2009) |
| Status | Terminated |
| Reason | Veridex has received 4 complaints regarding reagent bottles having been incorrectly placed or duplicate bottles places within the reagent tray of CellSearch Circulating Tumor Cell Kit. Delayed detection of disease relapse or progression may occur due to false low CTC results. |
| Root cause | Other |
| Action | Urgent Product Correction Notification letters were sent to all customers on August 12, 2009 by Federal Express. Customers were advised to inspect the kits to assure the proper reagents are in the proper position. If not, do not use the kits and contact the company at 877-837-4339 (chose option 1). |
| Quantity | 1641 in US, 380 internationally. |
| Distribution | Product was distributed worldwide, US (one government account: National Cancer Institute, Frederick, MD). Also 8 international accounts in Belgium, France, Germany, Italy, Spain, United Kingdom, Netherlands, Norway and Israel. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073338 | CELLSEARCH CIRCULATING TUMOR CELL KIT Veridex, LLC, Feb 26, 2008 |