Recall Z-2175-2010 ยท GKH Apparatus, Automated Blood Cell Diluting
Veridex, LLC
CellTracks Auto Prep System, Circulating Tumor Cell Kit (epithelial, IVD Veridex, LLC a Johnson & Johnson Company Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.
| Date | Aug 5, 2010 (initiated May 19, 2010) |
| Status | Terminated |
| Reason | Complaints of patient sample carryover. |
| Root cause | Process control |
| Action | On 19 May 2010, all consignees were notified, US and foreign, via Urgent Product Correction Notification letters. The letter identified the affected product and explained the reason for recall. Customers were asked to follow the required actions provided in the letter, including completing and returning the attached Confirmation of Receipt form. Questions should be directed to Customer Technical Services at 1-877-837-4339. |
| Quantity | 101 Domestically, 87 Internationally |
| Distribution | Worldwide distribution -- USA, China, Japan, England, France, Germany, Italy, Spain and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040077 | IMMUNICON CELLTRACKS AUTOPREP SYSTEM Immunicon Corp., Mar 12, 2004 |