CellSearch Circulating Tumor Cell Kit (Epithelial) IVD REF 7900001 Veridex LLC, a Johnson & Johnson Company.
FDA device recall Z-0819-2010 · posted 2010-02-23 · Terminated
Recall details
- Recalling firm
- Veridex, LLC
- Reason for recall
- Veridex has received 4 complaints regarding reagent bottles having been incorrectly placed or duplicate bottles places within the reagent tray of CellSearch Circulating Tumor Cell Kit. Delayed detection of disease relapse or progression may occur due to false low CTC results.
- Action taken
- Urgent Product Correction Notification letters were sent to all customers on August 12, 2009 by Federal Express. Customers were advised to inspect the kits to assure the proper reagents are in the proper position. If not, do not use the kits and contact the company at 877-837-4339 (chose option 1).
- Root cause
- Other
- Status
- Terminated
- Product code
- NQI
- Quantity affected
- 1641 in US, 380 internationally.
- Distribution
- Product was distributed worldwide, US (one government account: National Cancer Institute, Frederick, MD). Also 8 international accounts in Belgium, France, Germany, Italy, Spain, United Kingdom, Nethe
- Date initiated
- 2009-08-12
- Date posted
- 2010-02-23
- Date terminated
- 2012-07-18
- Location
- Raritan, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CELLSEARCH CIRCULATING TUMOR CELL KIT (K073338) | Veridex, LLC | 2008-02-26 |