Recall Z-1472-2011 ยท NRS Control Material, Blood Circulating Epithelial Cancer Cell
Veridex, LLC
Veridex, Cell Search Circulating Tumor Cell Control Kit. Product code 7900003
| Date | Mar 1, 2011 (initiated Nov 9, 2010) |
| Status | Terminated |
| Reason | There is a discrepancy between the assigned range of values on the high control label and the range listed on the Cell control Assigned Value Label for the Cell Search Circulating Tumor Cell Control Kit. |
| Root cause | Process control |
| Action | Veridex notified all affected consignees on November 11, 2010 by Federal Express overnight letter and prodivded with the informaiton regarding the label discrepancy. Foreign consignees were also notified on November 11, 2010 of the issue and instructed to notify their affected consignees. Consignees are asked to return the confirmation of receipt form by 11/29/2010. |
| Quantity | 122 US, 28 International |
| Distribution | Worldwide distribution, including: USA, Canada, France, UK, Germany, Italy, China, Spain & Portugal. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040898 | CELLSEARCH EPITHELIAL CELL CONTROL KIT Veridex, LLC, Jun 28, 2004 |