CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general p
FDA device recall Z-1949-2013 · posted 2013-08-10 · Terminated
Recall details
- Recalling firm
- Veridex, LLC
- Reason for recall
- Veridex, LLC has received a report that a patient's demographics were incorrectly associated with another patient's identification (PID) number. The purpose of this notification is to inform you of the issue and provide instructions to help prevent an occurrence on your CELLTRACKS AUTOPREP System and CELLTRACKS ANALYZER II.
- Action taken
- Veridex sent an Important Product Correction Notification letter dated December 28, 2012, to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the Confirmation of Receipt form. For questions contact Customer Technical Services at 1-800-421-3311.
- Root cause
- Software design
- Status
- Terminated
- Product code
- NQI
- Quantity affected
- US: 82 Units; Ex-US 78 Units.
- Distribution
- Worldwide Distribution - USA Nationwide and the countries of Australia, Canada, China, India, Japan, Singapore, England, France, Germany, Italy and Spain.
- Date initiated
- 2012-12-28
- Date posted
- 2013-08-10
- Date terminated
- 2015-08-11
- 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 AUTOPREP SYSTEM (K122821) | Veridex, LLC | 2012-12-13 |
| CELLTRACKS AUTOPREP SYSTEM (K110406) | Veridex, LLC | 2012-01-20 |