CellTracks Auto Prep System, Circulating Tumor Cell Kit (epithelial, IVD Veridex, LLC a Johnson & Johnson Company Intend
FDA device recall Z-2175-2010 · posted 2010-08-05 · Terminated
Recall details
- Recalling firm
- Veridex, LLC
- Reason for recall
- Complaints of patient sample carryover.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GKH
- Quantity affected
- 101 Domestically, 87 Internationally
- Distribution
- Worldwide distribution -- USA, China, Japan, England, France, Germany, Italy, Spain and Canada.
- Date initiated
- 2010-05-19
- Date posted
- 2010-08-05
- Date terminated
- 2014-05-08
- Location
- Raritan, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMMUNICON CELLTRACKS AUTOPREP SYSTEM (K040077) | Immunicon Corp. | 2004-03-12 |