FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2674-2011
- Recalling firm
- Caridian BCT, Incorporated
- Product
- 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.
- Status
- Terminated
- Initiated
- 2010-12-09
- Posted
- 2011-06-28
- Terminated
- 2011-09-12
- 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 available by contacting the CaridianBCT Support Center at 877-339-4228 or 303-231-4357.
- 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.
- Lot, serial or model codes
- Serial Numbers: 1P00100 thru 1P00719
- 510(k) numbers
- ["K071079","K103090"]
- PMA numbers
- not on file
- Product code
- LKN
- Firm FEI
- 1000117351
- Firm city
- Lakewood
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28