Recall Z-2674-2011 ยท LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Caridian BCT, Incorporated
Spectra Optia Apheresis System, REF: 61000, CaridianBCT, Lakewood, CO 80215. The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic apheresis applications. The system may be used to perform Therapeutic Plasma Exchange, Mononuclear Cell Collection, and Red Blood Cell Exchange.
| Date | Jun 28, 2011 (initiated Dec 9, 2010) |
| Status | Terminated |
| Reason | An additional air detection system is being added to all existing systems to detect air in the system's return line. |
| Root cause | Software design |
| Action | CaridianBCT sent a "MEDICAL DEVICE RECALL" letter dated December 2010 to all customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were advised to continue using their systems as long as they followed the instructions in the Operator's Manual. An Acknowledgement of Receipt form was included with the letter to be completed and faxed to 1-303-876-9277 or e-mailed to Regulatory.Affairs@caridianbct.com. A CaridianBCT representative will schedule a visit to facilities to upgrade their systems within the next 6 months. Further information is a |
| Quantity | 594 units |
| Distribution | Worldwide Distribution--USA (nationwide) and countries of Australia, Belgium, Canada, China, Hong Kong, Japan, Malaysia, Mexico, Pakistan, Saudi Arabia, Singapore, South Korea, Taiwan, Thailand, and Vietnam. |
| FDA record | Open on fda.gov |