Trima Accel Automated Blood Collection System, catalog number 917000000, Caridian BCT, Lakewood, CO 80215 USA. Product U
FDA device recall Z-1541-2012 · posted 2012-05-11 · Terminated
Recall details
- Recalling firm
- CaridianBCT, Inc.
- Reason for recall
- Labeling clarification and software updates to include fixes for end of run summaries, increasing boot reliability, corrections to the double red blood cell count collection TBV limit, and to be in compliance with the most current FDA guidance for post donation platelet count targets.
- Action taken
- CaridianBCT sent a Letter notification dated March 2011 to consignees The letter identified the upcoming software updates to version 6.0.1 as well as operations manual changes. For questions contact your CaridianBCT Representative, the CaridianBCT Support Center at +1-877-339-4228 or 1-303-231-4357 or your local CaridianBCT Customer Service office.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KZE
- Quantity affected
- 2278 units
- Distribution
- USA Nationwide Distribution
- Date initiated
- 2010-06-01
- Date posted
- 2012-05-11
- Date terminated
- 2012-07-25
- Location
- Lakewood, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZETAJET (K090003) | Bioject, Inc. | 2009-04-02 |