Recall Z-0191-2012 ยท LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Caridian BCT, Incorporated
Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. A blood component separator used for therapeutic plasma exchanges.
| Date | Nov 16, 2011 (initiated Sep 21, 2011) |
| Status | Terminated |
| Reason | Possible higher than expected platelet loss following therapeutic plasma exchange or plasmapheresis. |
| Root cause | Software design |
| Action | 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 lo |
| Quantity | 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 Arabia, Singapore, South Africa, Taiwan, Thailand and Vietnam. |
| FDA record | Open on fda.gov |