Recall Z-2175-2010
Veridex, LLC · initiated May 19, 2010
Product
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.
Codes / lots: Product code 9541
Reason for recall
Complaints of patient sample carryover.
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-2175-2010
- Initiated
- May 19, 2010
- Posted by FDA
- August 5, 2010
- Terminated
- May 8, 2014
- Product code
- GKH – Apparatus, Automated Blood Cell Diluting
- Quantity
- 101 Domestically, 87 Internationally
- Distribution
- Worldwide distribution -- USA, China, Japan, England, France, Germany, Italy, Spain and Canada.
- Recalling firm
- Veridex, LLC, Raritan, NJ