Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. A blood component separator used for therapeutic plasma exchanges.
This recall has been terminated (originally issued November 16, 2011).
- Company
- Caridian Bct, Incorporated
- Recall Initiated
- September 21, 2011
- Posted
- November 16, 2011
- Terminated
- February 1, 2013
- Recall Number
- Z-0191-2012
- Quantity
- 852 units (US: 333; Foreign: 519)
- Firm Location
- Lakewood, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Possible higher than expected platelet loss following therapeutic plasma exchange or plasmapheresis.
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 Arabia, Singapore, South Africa, Taiwan, Thailand and Vietnam.
Lot / Code Info
Serial Numbers: 1P00100 - 1P00XXX
Root Cause
Software design
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.