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.
FDA Recall Z-2674-2011 · Posted 2011-06-28
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Recalling FirmCaridian BCT, Incorporated
Recall StatusTerminated
Product CodeLKN
Date Initiated2010-12-09
Date Terminated2011-09-12
Product Quantity594 units
Reason for Recall
An additional air detection system is being added to all existing systems to detect air in the system's return line.
Firm 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 [email protected]. 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.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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