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.
This recall has been terminated (originally issued June 28, 2011).
- Company
- Caridian Bct, Incorporated
- Recall Initiated
- December 9, 2010
- Posted
- June 28, 2011
- Terminated
- September 12, 2011
- Recall Number
- Z-2674-2011
- Quantity
- 594 units
- Firm Location
- Lakewood, CO
- Official Source
- View on FDA website ↗
Reason for Recall
An additional air detection system is being added to all existing systems to detect air in the system's return line.
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.
Lot / Code Info
Serial Numbers: 1P00100 thru 1P00719
Root Cause
Software design
Action Taken
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 available by contacting the CaridianBCT Support Center at 877-339-4228 or 303-231-4357.