Cell Search Circulating Tumor Cell Kit (Epithelial) Veridex LLC, a Johnson & Johnson Company IVD Veridex, LLC 33 Technol
FDA device recall Z-1102-2007 · posted 2007-07-24 · Terminated
Recall details
- Recalling firm
- Veridex, LLC
- Reason for recall
- An increased incidence of aggregates was observed in Lot 0036 and 0036A. The presence of aggregates will cause customers to invalidate patient results.
- Action taken
- All Direct customers and customers of distributors received a customer notification informing them of the increased incidence of aggregates in cartridges on April 30, 2007 by Fed Ex overnight. This letter instructed them to discontinue use and to discard any remaining inventory. This was followed by a notification on May 24, 2007 by Fed Ex overnight to all US Distributors which also requested that they immediately stop using and/or distributing kits and to destroy any remaining inventory. Distributors were also asked to notifiy customers who received product. All foreign affiliate consignees were also informed on this date by e-mail and instructed to notify their customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- NQI
- Quantity affected
- Lot 0036: 468 kits; Lot 0036A: 197 kits
- Distribution
- The kits were distributed to hospitals and laboratories nationwide. They were also sent to 7 J&J affiliated companies in France, Japan, Canada, England, Germany, Italy and Spain.
- Date initiated
- 2007-04-17
- Date posted
- 2007-07-24
- Date terminated
- 2007-12-06
- Location
- Warren, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CELLSEARCH CIRCULATING TUMOR CELL KIT (K062013) | Veridex, LLC | 2006-12-14 |
| MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT (K052191) | Veridex, LLC | 2005-10-27 |
| CELLSEARCH CIRCULATING TUMOR CELL KIT (K050245) | Veridex, LLC | 2005-03-15 |