CellTracks Analyzer II. A semi-automated fluorescence microscope used to enumerate fluorescently labeled cells that are
FDA device recall Z-1004-2012 · posted 2012-02-13 · Terminated
Recall details
- Recalling firm
- Veridex, LLC
- Reason for recall
- Control cell images may i intermix with Patient cell images while changing between the Control review screen and Patient review screen on the Cell tracks Analyzer II.
- Action taken
- Veridex, LLC sent an "URGENT PRODUCT CORRECTION NOTIFICATION" letter dated August 17, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter provides procedure sheets with step by step directions for customers to follow. Additionally, a Confirmation of Receipt form was enclosed for customers to complete and return to the firm. Contact Customer Technical Services at 1-877-837-4339 for questions regarding this notice.
- Root cause
- Software design
- Status
- Terminated
- Product code
- NQI
- Quantity affected
- 37 Units
- Distribution
- Worldwide Distribution.
- Date initiated
- 2011-08-17
- Date posted
- 2012-02-13
- Date terminated
- 2015-06-17
- 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 |
|---|---|---|
| CELLTRACKS ANALYER II (K113181) | Veridex, LLC | 2011-12-12 |
| CELLTRACKS ANALYZER II (K060110) | Immunicon Corp. | 2006-03-16 |
| CELLTRACKA ANALYZER II (K050145) | Immunicon Corp. | 2005-03-15 |