CELLTRACKS ANALYZER II (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II is a semi-automated fluorescence mi
FDA device recall Z-1195-2014 · posted 2014-03-13 · Terminated
Recall details
- Recalling firm
- Veridex, LLC
- Reason for recall
- Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II.
- Action taken
- Janssen Diagnostics, LLC sent an Important Product Correction Notification letter dated January 8, 2014 to all affected customers via FedEx overnight courier letter and Foreign Affiliate Consignees by email on January 8, 2014. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the Confirmation of Receipt Response form attached. For questions contact Customer Technical Service at 1-877-837-4339.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NQI
- Quantity affected
- 19 units
- Distribution
- Worldwide Distribution - USA Nationwide
- Date initiated
- 2014-01-08
- Date posted
- 2014-03-13
- Date terminated
- 2017-07-06
- 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 ANALYZER II SYSTEM (K130794) | Veridex, LLC | 2013-06-20 |
| CELLTRACKA ANALYZER II (K050145) | Immunicon Corp. | 2005-03-15 |