Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. A blood component separator used for thera
FDA device recall Z-0191-2012 · posted 2011-11-16 · Terminated
Recall details
- Recalling firm
- Caridian BCT, Incorporated
- Reason for recall
- Possible higher than expected platelet loss following therapeutic plasma exchange or plasmapheresis.
- Action taken
- CaridianBCT sent a "Safety Alert" letter dated September 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm will be sending a recall letter to consignees in November 2011, stating they are voluntarily recalling the software and will provide an upgrade once the software has been approved. If you have any further questions please contact your CaridianBCT Representative, the CaridianBCT Support Center at 1-877-3-FYU-BCT ( US Toll free 1-877-299-4228 ) or (303) 231-HELP ) ( 1 (303) 231-4357, or your local CaridianBCT Customer Service office.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LKN
- Quantity affected
- 852 units (US: 333; Foreign: 519)
- Distribution
- Worldwide Distribution -- USA ( nationwide ) and the countries of Australia, Belgium, Canada, Chile, China, Colombia, Hong Kong, India, Japan, Malaysia, Mexico, Pakistan, Republic of Korea, Saudi Arab
- Date initiated
- 2011-09-21
- Date posted
- 2011-11-16
- Date terminated
- 2013-02-01
- 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 |
|---|---|---|
| SPECTRA OPTIA R APHERESIS SYSTEM (K103090) | Caridianbct, Inc.. | 2010-11-19 |
| SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200 (K071079) | Gambro Bct, Inc. | 2007-08-02 |